| 2026-05-21 |
Class II
|
Ongoing |
Z-2406-2026 |
MOSAIQ Oncology Information System |
— |
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. |
| 2026-03-19 |
Class II
|
Ongoing |
Z-2006-2026 |
Brand Name: Leksell Vantage Arc System REF: 1053958 |
— |
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. |
| 2026-02-18 |
Class II
|
Ongoing |
Z-1581-2026 |
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksel… |
— |
Due to adapter not being properly aligned or locked in place. |
| 2025-12-14 |
Class II
|
Ongoing |
Z-1164-2026 |
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD … |
— |
Due to a manufacturing issue and electrical grounding of systems. |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1340-2026 |
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Pr… |
— |
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This … |
| 2025-12-12 |
Class II
|
Ongoing |
Z-1339-2026 |
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product … |
— |
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This … |
| 2025-12-10 |
Class II
|
Ongoing |
Z-1078-2026 |
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) |
— |
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one fie… |
| 2025-09-30 |
Class II
|
Ongoing |
Z-0433-2026 |
Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Produ… |
— |
Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the… |
| 2025-01-15 |
Class II
|
Ongoing |
Z-1162-2025 |
MOSAIQ Oncology Information System |
— |
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale. |
| 2023-10-25 |
Class II
|
Ongoing |
Z-0447-2024 |
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear |
— |
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI de… |
| 2023-10-25 |
Class II
|
Ongoing |
Z-0446-2024 |
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy S… |
— |
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI de… |
| 2023-10-25 |
Class II
|
Ongoing |
Z-0445-2024 |
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear |
— |
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI de… |
| 2023-10-25 |
Class II
|
Ongoing |
Z-0444-2024 |
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accele… |
— |
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI de… |
| 2023-10-25 |
Class II
|
Ongoing |
Z-0443-2024 |
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Li… |
— |
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI de… |
| 2023-10-25 |
Class II
|
Ongoing |
Z-0442-2024 |
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Ac… |
— |
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI de… |
| 2023-05-05 |
Class II
|
Ongoing |
Z-1665-2023 |
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. El… |
— |
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601 |
| 2023-04-06 |
Class II
|
Ongoing |
Z-1675-2023 |
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil. |
— |
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems. |
| 2023-02-28 |
Class II
|
Ongoing |
Z-1233-2023 |
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy… |
— |
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation. |
| 2022-12-05 |
Class II
|
Ongoing |
Z-0719-2023 |
Oncentra Brachy radiation therapy planning system software. |
— |
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling |
| 2021-10-13 |
Class II
|
Ongoing |
Z-0182-2022 |
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 |
— |
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels. |
| 2021-09-17 |
Class II
|
Terminated |
Z-0116-2022 |
Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekt… |
— |
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the … |
| 2021-09-14 |
Class II
|
Ongoing |
Z-2563-2021 |
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation … |
— |
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that i… |
| 2021-09-02 |
Class II
|
Ongoing |
Z-2591-2021 |
MOSAIQ Oncology Information System |
— |
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value. |
| 2021-07-26 |
Class II
|
Ongoing |
Z-2406-2021 |
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 |
— |
If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch una… |
| 2021-04-20 |
Class II
|
Terminated |
Z-1783-2021 |
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud |
— |
Malware attack |
| 2020-05-21 |
Class II
|
Terminated |
Z-2297-2020 |
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571 |
— |
In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect t… |
| 2020-04-30 |
Class II
|
Terminated |
Z-2289-2020 |
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation ther… |
— |
potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray. |
| 2020-04-16 |
Class II
|
Ongoing |
Z-1825-2020 |
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make… |
— |
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate d… |
| 2020-03-30 |
Class II
|
Terminated |
Z-1826-2020 |
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic… |
— |
A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a L… |