| 2026-06-08 |
Class II
|
Ongoing |
Z-2648-2026 |
ARTIS icono ceiling. Model Number: 11328100. |
— |
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the su… |
| 2026-03-12 |
Class II
|
Ongoing |
Z-1814-2026 |
ARTIS Pheno VE30A and VE40A, Model 10849000 |
— |
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a… |
| 2026-03-10 |
Class II
|
Ongoing |
Z-1653-2026 |
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. |
— |
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing s… |
| 2025-12-29 |
Class II
|
Ongoing |
Z-1175-2026 |
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Ve… |
— |
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previo… |
| 2025-12-29 |
Class II
|
Ongoing |
Z-1174-2026 |
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Ve… |
— |
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previo… |
| 2025-12-19 |
Class II
|
Ongoing |
Z-1242-2026 |
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPE… |
— |
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. |
| 2025-12-19 |
Class II
|
Ongoing |
Z-1241-2026 |
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT AS… |
— |
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. |
| 2025-12-19 |
Class II
|
Ongoing |
Z-1240-2026 |
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS |
— |
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. |
| 2025-12-19 |
Class II
|
Ongoing |
Z-1239-2026 |
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS |
— |
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. |
| 2025-12-05 |
Class II
|
Ongoing |
Z-0999-2026 |
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 |
— |
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and witho… |
| 2025-10-24 |
Class II
|
Ongoing |
Z-0879-2026 |
MAMMOMAT Fusion; |
— |
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus install… |
| 2025-10-24 |
Class II
|
Ongoing |
Z-0878-2026 |
MAMMOMAT Inspiration; |
— |
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus install… |
| 2025-10-24 |
Class II
|
Ongoing |
Z-0877-2026 |
MAMMOMAT Revelation; |
— |
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus install… |
| 2025-10-01 |
Class I
|
Ongoing |
Z-0431-2026 |
MAGNETOM Cima.X Upgrade. Model Number: 11689304. |
— |
There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venti… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2668-2025 |
MAGNETOM Vida Fit. Model Number: 11410481. |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2667-2025 |
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693,… |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2666-2025 |
MAGNETOM Verio Dot Upgrade. Model Number: 10684334. |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2665-2025 |
MAGNETOM Verio Dot. Model Number: 10684333. |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2664-2025 |
MAGNETOM Verio. Model Number: 10276755. |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2663-2025 |
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Numbe… |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2662-2025 |
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2661-2025 |
MAGNETOM Skyra fit. Model Number: 10849580. |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2660-2025 |
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K1… |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2659-2025 |
MAGNETOM Prisma. Model Number: 10849582. |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2658-2025 |
MAGNETOM Lumina (DE). Model Number: 11344916. |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2657-2025 |
MAGNETOM Connectom.X. Model Number: 11371480. |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2656-2025 |
MAGNETOM Cima.X (DE). Model Number: 11647158. |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2655-2025 |
BIOGRAPH One (DE). Model Number: 11689172. |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-28 |
Class I
|
Ongoing |
Z-2654-2025 |
Biograph mMR. Model Number: 10433372. |
— |
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to esca… |
| 2025-08-12 |
Class II
|
Ongoing |
Z-2529-2025 |
Artis Pheno. Image-Intensified Flouroscopic X-Ray System. |
— |
Limited system movements after startup . |
| 2025-06-04 |
Class II
|
Ongoing |
Z-1982-2025 |
UROSKOP Omnia Max. Model Number: 10762473 |
— |
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire. |
| 2025-06-04 |
Class II
|
Ongoing |
Z-1981-2025 |
UROSKOP Omnia. Model Number: 10094910 |
— |
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire. |
| 2025-05-15 |
Class II
|
Ongoing |
Z-2022-2025 |
interventional fluoroscopic x-ray system |
— |
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, t… |
| 2025-05-15 |
Class II
|
Ongoing |
Z-2021-2025 |
interventional fluoroscopic x-ray system |
— |
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, t… |
| 2025-05-15 |
Class II
|
Ongoing |
Z-2020-2025 |
interventional fluoroscopic x-ray system |
— |
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, t… |
| 2025-05-15 |
Class II
|
Ongoing |
Z-2019-2025 |
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and intervention… |
— |
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, t… |
| 2025-01-02 |
Class II
|
Ongoing |
Z-0922-2025 |
ARTIS One Angiographic X-Ray System |
— |
A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with … |
| 2024-08-15 |
Class II
|
Ongoing |
Z-3217-2024 |
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultraso… |
— |
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/m… |
| 2024-08-15 |
Class II
|
Ongoing |
Z-3216-2024 |
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software |
— |
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/m… |
| 2024-08-15 |
Class II
|
Ongoing |
Z-3215-2024 |
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.… |
— |
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/m… |
| 2024-07-03 |
Class II
|
Ongoing |
Z-2441-2024 |
Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting h… |
— |
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator… |
| 2024-07-03 |
Class II
|
Ongoing |
Z-2440-2024 |
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended … |
— |
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator… |
| 2024-07-03 |
Class II
|
Ongoing |
Z-2439-2024 |
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be u… |
— |
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator… |
| 2024-07-03 |
Class II
|
Ongoing |
Z-2438-2024 |
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a dia… |
— |
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator… |
| 2024-07-02 |
Class II
|
Ongoing |
Z-2528-2024 |
Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Num… |
— |
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays |
| 2024-07-02 |
Class II
|
Ongoing |
Z-2527-2024 |
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Mode… |
— |
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays |
| 2024-07-02 |
Class II
|
Ongoing |
Z-2526-2024 |
Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model… |
— |
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays |
| 2024-07-02 |
Class II
|
Ongoing |
Z-2525-2024 |
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Mod… |
— |
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays |
| 2024-05-31 |
Class II
|
Ongoing |
Z-2188-2024 |
ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emerge… |
— |
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 |
Class II
|
Ongoing |
Z-2187-2024 |
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the… |
— |
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 |
Class II
|
Ongoing |
Z-2186-2024 |
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the… |
— |
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 |
Class II
|
Ongoing |
Z-2185-2024 |
AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients… |
— |
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 |
Class II
|
Ongoing |
Z-2184-2024 |
AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as wel… |
— |
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 |
Class II
|
Ongoing |
Z-2183-2024 |
AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO a… |
— |
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 |
Class II
|
Ongoing |
Z-2182-2024 |
AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO … |
— |
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 |
Class II
|
Ongoing |
Z-2181-2024 |
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO … |
— |
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 |
Class II
|
Ongoing |
Z-2180-2024 |
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO a… |
— |
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-03-21 |
Class II
|
Ongoing |
Z-1598-2024 |
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 1… |
— |
Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and th… |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1601-2024 |
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version V… |
— |
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements… |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1600-2024 |
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G |
— |
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements… |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1599-2024 |
ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF:… |
— |
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0683-2024 |
Sensis Vibe Hemo |
— |
The possibility of the Sensis documentation functionality application to crash. |
| 2023-10-17 |
Class II
|
Ongoing |
Z-0523-2024 |
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100 |
— |
Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is s… |
| 2023-10-05 |
Class II
|
Ongoing |
Z-0223-2024 |
Mobilett Mira wireless (VA20) mobile x-ray system(s) |
— |
Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray… |
| 2023-09-12 |
Class II
|
Ongoing |
Z-0196-2024 |
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment… |
— |
Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required … |
| 2023-09-12 |
Class II
|
Ongoing |
Z-0195-2024 |
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200 |
— |
Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required … |
| 2023-09-01 |
Class II
|
Ongoing |
Z-2648-2023 |
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mic… |
— |
In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense arti… |
| 2023-07-13 |
Class II
|
Ongoing |
Z-2582-2023 |
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 |
— |
If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will displa… |
| 2023-07-12 |
Class II
|
Ongoing |
Z-2256-2023 |
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sens… |
— |
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and … |
| 2023-06-19 |
Class II
|
Ongoing |
Z-2361-2023 |
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Mate… |
— |
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoros… |
| 2023-06-19 |
Class II
|
Ongoing |
Z-2360-2023 |
ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.… |
— |
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoros… |
| 2023-06-19 |
Class II
|
Ongoing |
Z-2359-2023 |
ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedur… |
— |
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoros… |
| 2023-06-05 |
Class II
|
Ongoing |
Z-2240-2023 |
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive … |
— |
Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk of… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1469-2023 |
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Ma… |
— |
Examination room monitor connected with the hybrid cable may have a display issue and no image function is available |
| 2023-02-02 |
Class II
|
Ongoing |
Z-1498-2023 |
ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for s… |
— |
If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated wh… |
| 2023-02-02 |
Class II
|
Ongoing |
Z-1311-2023 |
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material #… |
— |
In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator,… |
| 2023-01-16 |
Class II
|
Ongoing |
Z-1136-2023 |
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge |
— |
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. |
| 2023-01-16 |
Class II
|
Ongoing |
Z-1135-2023 |
SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R… |
— |
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. |
| 2023-01-16 |
Class II
|
Ongoing |
Z-1134-2023 |
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission |
— |
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. |
| 2022-12-22 |
Class II
|
Ongoing |
Z-1003-2023 |
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Use… |
— |
In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segme… |
| 2022-12-21 |
Class II
|
Ongoing |
Z-1168-2023 |
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Mode… |
— |
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of t… |
| 2022-12-21 |
Class II
|
Ongoing |
Z-1167-2023 |
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie M… |
— |
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of t… |
| 2022-12-21 |
Class II
|
Ongoing |
Z-1166-2023 |
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10… |
— |
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of t… |
| 2022-12-21 |
Class II
|
Ongoing |
Z-1165-2023 |
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Mod… |
— |
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of t… |
| 2022-12-21 |
Class II
|
Ongoing |
Z-1164-2023 |
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number… |
— |
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of t… |
| 2022-12-16 |
Class II
|
Ongoing |
Z-1040-2023 |
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee b… |
— |
In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is… |
| 2022-12-16 |
Class II
|
Ongoing |
Z-0956-2023 |
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor |
— |
Mechanical connection between the tabletop and table base may be lost. |
| 2022-12-09 |
Class II
|
Ongoing |
Z-1002-2023 |
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max |
— |
There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pat… |
| 2022-12-09 |
Class II
|
Ongoing |
Z-1001-2023 |
AXIOM Luminos Agile |
— |
There is potential for the footrest to detach from the patient table during use. |
| 2022-12-09 |
Class II
|
Ongoing |
Z-1000-2023 |
AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF |
— |
There is potential for the footrest to detach from the patient table during use. |
| 2022-11-23 |
Class II
|
Ongoing |
Z-1481-2023 |
LUMINOS Lotus Max (VF11) |
— |
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/… |
| 2022-11-23 |
Class II
|
Ongoing |
Z-1480-2023 |
Luminos dRF Max (VE10, VF10, VF11) |
— |
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/… |
| 2022-11-23 |
Class II
|
Ongoing |
Z-1479-2023 |
Luminos Agile Max (VE10, VF10, VF11) |
— |
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/… |
| 2022-11-16 |
Class II
|
Ongoing |
Z-0775-2023 |
Programmable Diagnostic Computer |
— |
The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software i… |
| 2022-11-09 |
Class II
|
Ongoing |
Z-0472-2023 |
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intend… |
— |
When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter |
| 2022-09-20 |
Class II
|
Ongoing |
Z-0119-2023 |
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 |
— |
Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for pat… |
| 2022-08-10 |
Class II
|
Ongoing |
Z-1647-2022 |
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700 |
— |
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rar… |
| 2022-08-10 |
Class II
|
Ongoing |
Z-1646-2022 |
Artis pheno- Model No. 10849000 |
— |
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rar… |
| 2022-08-10 |
Class II
|
Ongoing |
Z-1645-2022 |
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zee… |
— |
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rar… |
| 2022-07-12 |
Class III
|
Terminated |
Z-1558-2022 |
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Co… |
— |
The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory ra… |
| 2022-06-15 |
Class II
|
Ongoing |
Z-1426-2022 |
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizat… |
— |
Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer… |
| 2022-06-15 |
Class II
|
Ongoing |
Z-1425-2022 |
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/o… |
— |
Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer… |
| 2022-06-10 |
Class II
|
Ongoing |
Z-1294-2022 |
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000 |
— |
A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail … |
| 2022-05-24 |
Class II
|
Terminated |
Z-1343-2022 |
Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System |
— |
It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If th… |
| 2022-05-20 |
Class II
|
Ongoing |
Z-1342-2022 |
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 |
— |
During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfu… |
| 2022-04-13 |
Class II
|
Ongoing |
Z-1243-2022 |
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 … |
— |
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patient… |
| 2022-04-11 |
Class II
|
Ongoing |
Z-1246-2022 |
Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures … |
— |
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an elec… |
| 2022-04-11 |
Class II
|
Ongoing |
Z-1245-2022 |
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedur… |
— |
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an elec… |
| 2022-03-11 |
Class II
|
Terminated |
Z-0893-2022 |
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems |
— |
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue. |
| 2022-03-07 |
Class II
|
Ongoing |
Z-1010-2022 |
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only , |
— |
Transducers (component of ultrasound system) may exceed recommended thermal index limits |
| 2022-03-07 |
Class II
|
Terminated |
Z-0997-2022 |
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers wit… |
— |
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinat… |
| 2022-03-07 |
Class II
|
Terminated |
Z-0996-2022 |
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syng… |
— |
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinat… |
| 2022-03-07 |
Class II
|
Terminated |
Z-0995-2022 |
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syng… |
— |
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinat… |
| 2022-03-07 |
Class II
|
Terminated |
Z-0994-2022 |
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via… |
— |
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinat… |
| 2022-03-07 |
Class II
|
Ongoing |
Z-0962-2022 |
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 110616… |
— |
Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software err… |
| 2022-03-07 |
Class II
|
Ongoing |
Z-0730-2022 |
YSIO X.Pree |
— |
For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. Dur… |
| 2022-02-25 |
Class II
|
Ongoing |
Z-1339-2022 |
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as foll… |
— |
After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientati… |
| 2022-02-25 |
Class II
|
Ongoing |
Z-0987-2022 |
Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and bipl… |
— |
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). T… |
| 2022-02-25 |
Class II
|
Ongoing |
Z-0986-2022 |
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single an… |
— |
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). T… |
| 2022-02-25 |
Class II
|
Ongoing |
Z-0985-2022 |
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single… |
— |
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). T… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0980-2022 |
Artis Q.zen biplane, Model Number 10848355 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0979-2022 |
Artis Q.zen ceiling, Model Number 10848354 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0978-2022 |
Artis Q.zen floor, Model Number 10848353 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0977-2022 |
Artis Q zeego, Model Number 10848283 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0976-2022 |
Artis Q biplane, Model Number 10848282 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0975-2022 |
Artis Q ceiling, Model Number 10848281 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0974-2022 |
Artis Q floor, Model Number 10848280 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0973-2022 |
Artis zeego, Model Number 10280959 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0972-2022 |
Artis zee biplane MN, Model Number 10094143 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0971-2022 |
Artis zee floor MN, Model Number 10094142 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0970-2022 |
Artis zee biplane, Model Number 10094141 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0969-2022 |
Artis zee multi-purpose, Model Number 10094139 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0968-2022 |
Artis zee ceiling, Model Number 10094137 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-02-23 |
Class II
|
Ongoing |
Z-0967-2022 |
Artis zee floor, Model Number 10094135 |
— |
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled… |
| 2022-01-31 |
Class II
|
Ongoing |
Z-0841-2022 |
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system |
— |
Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect inter… |
| 2022-01-19 |
Class II
|
Ongoing |
Z-0748-2022 |
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging s… |
— |
The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultr… |
| 2021-12-09 |
Class II
|
Terminated |
Z-0441-2022 |
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therap… |
— |
Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the … |
| 2021-11-23 |
Class II
|
Ongoing |
Z-0499-2022 |
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. S… |
— |
Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, … |
| 2021-11-19 |
Class II
|
Ongoing |
Z-0475-2022 |
SOMATOM Definition Edge -Computed tomography system Model 10590000 |
— |
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. |
| 2021-11-19 |
Class II
|
Ongoing |
Z-0474-2022 |
SOMATOM Edge Plus-Computed tomography system Model 1026700 |
— |
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. |
| 2021-11-19 |
Class II
|
Ongoing |
Z-0473-2022 |
SOMATOM Definition AS-Computed tomography system Model 8098027 |
— |
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. |
| 2021-11-19 |
Class II
|
Ongoing |
Z-0472-2022 |
SOMATOM Confidence -Computed tomography systems Model 10590100 |
— |
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. |
| 2021-11-12 |
Class II
|
Ongoing |
Z-0547-2022 |
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B |
— |
Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially resul… |
| 2021-10-20 |
Class II
|
Terminated |
Z-0305-2022 |
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and inte… |
— |
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try aga… |
| 2021-10-20 |
Class II
|
Terminated |
Z-0304-2022 |
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and inter… |
— |
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try aga… |
| 2021-10-20 |
Class II
|
Terminated |
Z-0303-2022 |
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interve… |
— |
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try aga… |
| 2021-10-20 |
Class II
|
Terminated |
Z-0302-2022 |
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and intervent… |
— |
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try aga… |
| 2021-10-20 |
Class II
|
Terminated |
Z-0301-2022 |
Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and intervent… |
— |
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try aga… |
| 2021-10-20 |
Class II
|
Terminated |
Z-0300-2022 |
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventi… |
— |
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try aga… |
| 2021-10-20 |
Class II
|
Terminated |
Z-0299-2022 |
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interve… |
— |
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try aga… |
| 2021-10-20 |
Class II
|
Terminated |
Z-0298-2022 |
Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and i… |
— |
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try aga… |
| 2021-10-20 |
Class II
|
Terminated |
Z-0297-2022 |
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interve… |
— |
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try aga… |
| 2021-10-20 |
Class II
|
Terminated |
Z-0296-2022 |
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and intervent… |
— |
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try aga… |
| 2021-10-12 |
Class II
|
Terminated |
Z-0517-2022 |
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700 |
— |
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+… |
| 2021-10-12 |
Class II
|
Terminated |
Z-0516-2022 |
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600 |
— |
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+… |
| 2021-10-12 |
Class II
|
Terminated |
Z-0515-2022 |
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000 |
— |
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+… |
| 2021-10-05 |
Class II
|
Ongoing |
Z-0226-2022 |
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641… |
— |
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is… |
| 2021-09-24 |
Class II
|
Ongoing |
Z-0200-2022 |
Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/… |
— |
Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either directi… |
| 2021-08-30 |
Class II
|
Terminated |
Z-0289-2022 |
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000 |
— |
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resu… |
| 2021-08-30 |
Class II
|
Terminated |
Z-0288-2022 |
SOMATOM Confidence with software syngo.CT VB20 Model #10590100 |
— |
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resu… |
| 2021-08-30 |
Class II
|
Terminated |
Z-0287-2022 |
SOMATOM Drive with software syngo.CT VB20 Model #10431700 |
— |
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resu… |
| 2021-08-30 |
Class II
|
Terminated |
Z-0286-2022 |
SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603 |
— |
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resu… |
| 2021-08-30 |
Class II
|
Terminated |
Z-0285-2022 |
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000 |
— |
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resu… |
| 2021-08-30 |
Class II
|
Terminated |
Z-0284-2022 |
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027 |
— |
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resu… |
| 2021-08-30 |
Class II
|
Terminated |
Z-0283-2022 |
SOMATOM Force with software syngo.CT VB20 Model #10742326 |
— |
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resu… |
| 2021-08-18 |
Class II
|
Ongoing |
Z-2500-2021 |
Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_F… |
— |
Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also … |
| 2021-08-16 |
Class II
|
Ongoing |
Z-2447-2021 |
MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHE… |
— |
Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an i… |
| 2021-08-16 |
Class II
|
Ongoing |
Z-2446-2021 |
syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.A… |
— |
Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an i… |
| 2021-08-16 |
Class II
|
Ongoing |
Z-2445-2021 |
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material … |
— |
Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an i… |
| 2021-07-12 |
Class II
|
Terminated |
Z-2471-2021 |
ACUSON Juniper Diagnostic Ultrasound System |
— |
Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable. |
| 2021-06-30 |
Class II
|
Terminated |
Z-2404-2021 |
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 1009… |
— |
Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment |
| 2021-05-27 |
Class II
|
Ongoing |
Z-2029-2021 |
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Mod… |
— |
Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm… |
| 2021-04-20 |
Class II
|
Terminated |
Z-1685-2021 |
Multitom RAX with software version VF10 |
— |
Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not hit the detector. This… |
| 2021-03-30 |
Class II
|
Terminated |
Z-1496-2021 |
Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventi… |
— |
Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corro… |
| 2021-03-26 |
Class II
|
Ongoing |
Z-1495-2021 |
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137 |
— |
Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient… |
| 2021-03-19 |
Class II
|
Terminated |
Z-1497-2021 |
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849… |
— |
Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray sy… |
| 2021-03-10 |
Class II
|
Terminated |
Z-1346-2021 |
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body in… |
— |
A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during init… |
| 2021-03-04 |
Class II
|
Terminated |
Z-1434-2021 |
Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processin… |
— |
Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure… |
| 2021-03-03 |
Class II
|
Terminated |
Z-1253-2021 |
Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go… |
— |
SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and … |
| 2021-02-26 |
Class II
|
Terminated |
Z-1288-2021 |
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interv… |
— |
Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power suppl… |
| 2021-02-04 |
Class II
|
Ongoing |
Z-1330-2021 |
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual sta… |
— |
The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may re… |
| 2021-01-27 |
Class II
|
Terminated |
Z-1173-2021 |
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrati… |
— |
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system |
| 2020-12-18 |
Class II
|
Terminated |
Z-1144-2021 |
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usa… |
— |
Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential… |
| 2020-11-30 |
Class II
|
Ongoing |
Z-0656-2021 |
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno |
— |
When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", th… |
| 2020-11-24 |
Class II
|
Terminated |
Z-0771-2021 |
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus |
— |
System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need f… |
| 2020-10-21 |
Class II
|
Terminated |
Z-0469-2021 |
Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 108… |
— |
Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate,… |
| 2020-09-21 |
Class II
|
Terminated |
Z-0298-2021 |
Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he… |
— |
Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution). |
| 2020-09-18 |
Class II
|
Terminated |
Z-0400-2021 |
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angio… |
— |
There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when th… |
| 2020-09-09 |
Class II
|
Terminated |
Z-0806-2021 |
Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for u… |
— |
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor supp… |
| 2020-09-09 |
Class II
|
Terminated |
Z-0805-2021 |
Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urolo… |
— |
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor supp… |
| 2020-08-19 |
Class II
|
Terminated |
Z-3005-2020 |
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used… |
— |
Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjust… |
| 2020-08-14 |
Class II
|
Terminated |
Z-2934-2020 |
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribu… |
— |
This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations… |
| 2020-08-03 |
Class II
|
Terminated |
Z-0108-2021 |
Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventiona… |
— |
Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collisio… |
| 2020-07-30 |
Class II
|
Terminated |
Z-2888-2020 |
Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designe… |
— |
Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated … |
| 2020-07-30 |
Class II
|
Terminated |
Z-2887-2020 |
Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system design… |
— |
Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated … |
| 2020-07-24 |
Class II
|
Terminated |
Z-2921-2020 |
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool suppo… |
— |
The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under … |
| 2020-07-14 |
Class II
|
Terminated |
Z-2848-2020 |
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Al… |
— |
Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part… |
| 2020-06-24 |
Class II
|
Terminated |
Z-2688-2020 |
syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 |
— |
If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orie… |
| 2020-06-22 |
Class II
|
Terminated |
Z-3025-2020 |
Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definiti… |
— |
Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patien… |
| 2020-05-22 |
Class II
|
Terminated |
Z-0090-2021 |
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F |
— |
Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block. |
| 2020-05-07 |
Class II
|
Terminated |
Z-2388-2020 |
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagno… |
— |
If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement rang… |
| 2020-04-30 |
Class II
|
Terminated |
Z-2302-2020 |
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor … |
— |
Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interrup… |
| 2020-04-23 |
Class II
|
Terminated |
Z-2257-2020 |
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoros… |
— |
Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in… |
| 2020-04-22 |
Class II
|
Terminated |
Z-2108-2020 |
ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiog… |
— |
If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be re… |
| 2020-04-20 |
Class II
|
Terminated |
Z-1959-2020 |
Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mob… |
— |
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system display… |
| 2020-04-20 |
Class II
|
Terminated |
Z-1958-2020 |
Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray syste… |
— |
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system display… |
| 2020-04-20 |
Class II
|
Terminated |
Z-1957-2020 |
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system… |
— |
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system display… |
| 2020-04-17 |
Class II
|
Terminated |
Z-2128-2020 |
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194 |
— |
The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. Th… |
| 2020-04-17 |
Class II
|
Terminated |
Z-2127-2020 |
Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha … |
— |
The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. Th… |
| 2020-04-06 |
Class II
|
Terminated |
Z-1765-2020 |
System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray… |
— |
It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pre… |
| 2020-04-06 |
Class II
|
Terminated |
Z-1764-2020 |
System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisitio… |
— |
It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pre… |
| 2020-02-18 |
Class II
|
Terminated |
Z-1680-2020 |
PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 |
— |
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. |
| 2020-02-18 |
Class II
|
Terminated |
Z-1679-2020 |
ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with D… |
— |
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. |
| 2020-02-18 |
Class II
|
Terminated |
Z-1678-2020 |
MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #019407… |
— |
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. |
| 2020-02-18 |
Class II
|
Terminated |
Z-1677-2020 |
ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 |
— |
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. |
| 2020-02-14 |
Class II
|
Terminated |
Z-1497-2020 |
Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Ar… |
— |
A software issue could potentially cause the stand and table movements to be blocked. |
| 2020-02-14 |
Class II
|
Terminated |
Z-1496-2020 |
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 … |
— |
A software issue could potentially cause the stand and table movements to be blocked. |
| 2020-02-14 |
Class II
|
Terminated |
Z-1495-2020 |
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q z… |
— |
A software issue could potentially cause the stand and table movements to be blocked. |
| 2020-02-10 |
Class II
|
Terminated |
Z-1501-2020 |
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system. |
— |
The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transv… |
| 2020-01-24 |
Class II
|
Terminated |
Z-1340-2020 |
ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of … |
— |
Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the … |
| 2020-01-16 |
Class II
|
Terminated |
Z-1346-2020 |
COHERENCE Oncologist, Model Nos. 07333680 & 07351898 |
— |
A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in … |
| 2020-01-08 |
Class II
|
Terminated |
Z-2758-2020 |
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device … |
— |
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max syste… |
| 2020-01-08 |
Class II
|
Terminated |
Z-2757-2020 |
SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical s… |
— |
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max syste… |
| 2020-01-08 |
Class II
|
Terminated |
Z-2756-2020 |
SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical s… |
— |
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max syste… |
| 2020-01-08 |
Class II
|
Terminated |
Z-2755-2020 |
SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical stru… |
— |
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max syste… |
| 2020-01-08 |
Class II
|
Terminated |
Z-1339-2020 |
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medi… |
— |
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis. |
| 2020-01-08 |
Class II
|
Terminated |
Z-1338-2020 |
Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical st… |
— |
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis. |
| 2020-01-08 |
Class II
|
Terminated |
Z-1337-2020 |
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical struct… |
— |
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis. |
| 2020-01-08 |
Class II
|
Terminated |
Z-1333-2020 |
Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical st… |
— |
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or pers… |
| 2020-01-08 |
Class II
|
Terminated |
Z-1332-2020 |
Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical st… |
— |
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or pers… |
| 2020-01-08 |
Class II
|
Terminated |
Z-1331-2020 |
Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical struct… |
— |
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or pers… |