| 2026-06-05 |
Class II
|
Ongoing |
Z-2728-2026 |
Optima XR240amx, Mobile Digital Radiographic System |
— |
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pa… |
| 2026-06-05 |
Class II
|
Ongoing |
Z-2727-2026 |
Optima XR220amx, Mobile Digital-Ready Radiographic System |
— |
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pa… |
| 2026-06-05 |
Class II
|
Ongoing |
Z-2726-2026 |
Optima XR200amx, Mobile Digital-Ready Radiographic System |
— |
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pa… |
| 2026-03-26 |
Class II
|
Ongoing |
Z-2155-2026 |
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 |
— |
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used … |
| 2026-03-26 |
Class II
|
Ongoing |
Z-2154-2026 |
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 |
— |
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used … |
| 2026-03-26 |
Class II
|
Ongoing |
Z-2153-2026 |
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 |
— |
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used … |
| 2026-03-26 |
Class II
|
Ongoing |
Z-2152-2026 |
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 |
— |
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used … |
| 2026-03-26 |
Class II
|
Ongoing |
Z-2151-2026 |
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 |
— |
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used … |
| 2026-03-26 |
Class II
|
Ongoing |
Z-2150-2026 |
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 |
— |
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used … |
| 2026-03-26 |
Class II
|
Ongoing |
Z-2149-2026 |
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300 |
— |
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used … |
| 2026-02-03 |
Class II
|
Ongoing |
Z-1590-2026 |
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E8… |
— |
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position. |
| 2026-01-30 |
Class II
|
Ongoing |
Z-1571-2026 |
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (inclu… |
— |
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local c… |
| 2026-01-30 |
Class II
|
Ongoing |
Z-1570-2026 |
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including… |
— |
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local c… |
| 2026-01-30 |
Class II
|
Ongoing |
Z-1569-2026 |
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including … |
— |
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local c… |
| 2025-10-24 |
Class II
|
Ongoing |
Z-0875-2026 |
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography |
— |
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j). |
| 2025-09-18 |
Class II
|
Ongoing |
Z-0157-2026 |
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533 |
— |
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to i… |
| 2025-09-18 |
Class II
|
Ongoing |
Z-0156-2026 |
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535 |
— |
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to i… |
| 2025-09-18 |
Class II
|
Ongoing |
Z-0155-2026 |
LOGIQ P10 series with software version R4.5.7 Model Number 5877534 |
— |
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to i… |
| 2025-08-22 |
Class II
|
Ongoing |
Z-0231-2026 |
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Nu… |
— |
If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cab… |
| 2025-07-02 |
Class II
|
Ongoing |
Z-2342-2025 |
GE HealthCare OEC 9900 Elite C-arm Systems. |
— |
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems a… |
| 2025-07-02 |
Class II
|
Ongoing |
Z-2341-2025 |
GE HealthCare OEC 9800. |
— |
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems a… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2320-2025 |
GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2319-2025 |
GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2318-2025 |
GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2317-2025 |
GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2316-2025 |
GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2315-2025 |
GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2314-2025 |
GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2313-2025 |
GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2312-2025 |
GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2311-2025 |
GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2310-2025 |
GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2309-2025 |
GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2308-2025 |
GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2307-2025 |
GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2306-2025 |
GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2305-2025 |
GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2304-2025 |
GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2303-2025 |
GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2302-2025 |
GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2301-2025 |
GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2300-2025 |
GE Signa Voyager, Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2299-2025 |
GE Signa Artist, Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premie… |
| 2025-05-23 |
Class II
|
Ongoing |
Z-2133-2025 |
SIGNA PET/MR |
— |
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce ele… |
| 2025-05-23 |
Class II
|
Ongoing |
Z-2132-2025 |
Discovery MR750w 3.0T |
— |
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce ele… |
| 2025-05-23 |
Class II
|
Ongoing |
Z-2131-2025 |
SIGNA Architect AIR |
— |
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce ele… |
| 2025-05-23 |
Class II
|
Ongoing |
Z-2130-2025 |
SIGNA Architect |
— |
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce ele… |
| 2025-03-21 |
Class II
|
Ongoing |
Z-1820-2025 |
OEC 3D |
— |
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. |
| 2025-03-21 |
Class II
|
Ongoing |
Z-1819-2025 |
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy… |
— |
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. |
| 2025-03-06 |
Class II
|
Ongoing |
Z-1556-2025 |
Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system… |
— |
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire. |
| 2025-03-06 |
Class II
|
Ongoing |
Z-1555-2025 |
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H… |
— |
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire. |
| 2025-02-18 |
Class II
|
Ongoing |
Z-1303-2025 |
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed |
— |
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the … |
| 2025-02-18 |
Class II
|
Ongoing |
Z-1302-2025 |
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed |
— |
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the … |
| 2025-02-18 |
Class II
|
Ongoing |
Z-1301-2025 |
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed |
— |
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the … |
| 2025-02-18 |
Class II
|
Ongoing |
Z-1300-2025 |
GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed |
— |
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the … |
| 2025-02-18 |
Class II
|
Ongoing |
Z-1299-2025 |
GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed |
— |
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the … |
| 2025-02-18 |
Class II
|
Ongoing |
Z-1298-2025 |
GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed |
— |
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the … |
| 2025-02-18 |
Class II
|
Ongoing |
Z-1297-2025 |
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed |
— |
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the … |
| 2025-01-28 |
Class II
|
Ongoing |
Z-1046-2025 |
Optima XR646 HD. X-Ray imaging system. |
— |
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or … |
| 2025-01-28 |
Class II
|
Ongoing |
Z-1045-2025 |
Discovery XR656 HD. X-Ray imaging system. |
— |
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or … |
| 2025-01-28 |
Class II
|
Ongoing |
Z-1044-2025 |
Discovery XR656HD. X-Ray imaging system. |
— |
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or … |
| 2025-01-28 |
Class II
|
Ongoing |
Z-1043-2025 |
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system. |
— |
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or … |
| 2024-12-06 |
Class II
|
Ongoing |
Z-0918-2025 |
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile … |
— |
There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time. |
| 2024-11-25 |
Class II
|
Ongoing |
Z-0813-2025 |
GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3… |
— |
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safet… |
| 2024-11-25 |
Class II
|
Ongoing |
Z-0812-2025 |
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3)… |
— |
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safet… |
| 2024-11-25 |
Class II
|
Ongoing |
Z-0811-2025 |
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) … |
— |
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safet… |
| 2024-11-18 |
Class II
|
Ongoing |
Z-0818-2025 |
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV |
— |
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| 2024-11-18 |
Class II
|
Ongoing |
Z-0817-2025 |
Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO |
— |
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| 2024-11-18 |
Class II
|
Ongoing |
Z-0816-2025 |
Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV |
— |
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| 2024-11-18 |
Class II
|
Ongoing |
Z-0815-2025 |
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO |
— |
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| 2024-11-18 |
Class II
|
Ongoing |
Z-0814-2025 |
Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610… |
— |
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| 2024-10-28 |
Class II
|
Ongoing |
Z-0520-2025 |
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVER… |
— |
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning… |
| 2024-10-28 |
Class II
|
Ongoing |
Z-0519-2025 |
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System |
— |
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning… |
| 2024-10-28 |
Class II
|
Ongoing |
Z-0518-2025 |
SIGNA Architect, Nuclear Magnetic Resonance Imaging System |
— |
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning… |
| 2024-10-28 |
Class II
|
Ongoing |
Z-0517-2025 |
Discovery MR750w 3.0T, whole body magnetic resonance scanner |
— |
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2484-2024 |
SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2483-2024 |
SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2482-2024 |
Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2481-2024 |
SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use on… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2480-2024 |
SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2479-2024 |
SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2478-2024 |
Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging Syste… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2477-2024 |
Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2476-2024 |
SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2475-2024 |
SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2474-2024 |
SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2473-2024 |
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Ima… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2472-2024 |
SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nucle… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2471-2024 |
1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2470-2024 |
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magne… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2469-2024 |
SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonan… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2468-2024 |
Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Ma… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2467-2024 |
Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imagi… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2466-2024 |
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emi… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2465-2024 |
Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2464-2024 |
Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2463-2024 |
3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2462-2024 |
SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Mag… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2461-2024 |
SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2460-2024 |
SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR3… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2459-2024 |
SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1,… |
— |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low S… |
| 2022-11-16 |
Class II
|
Ongoing |
Z-0733-2023 |
B125M Patient Monitor, REF 6160000-005-XXXXXXX |
— |
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 m… |
| 2022-11-16 |
Class II
|
Ongoing |
Z-0732-2023 |
B125M Patient Monitor, REF 6160000-004-XXXXXX |
— |
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 m… |
| 2022-11-16 |
Class II
|
Ongoing |
Z-0731-2023 |
B105M Patient Monitor, REF 6160000-003 |
— |
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 m… |
| 2022-11-16 |
Class II
|
Ongoing |
Z-0730-2023 |
B125P Patient Monitor (with E-module slot option), REF 6160000-002 |
— |
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 m… |
| 2022-11-16 |
Class II
|
Ongoing |
Z-0729-2023 |
B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX, |
— |
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 m… |
| 2022-11-10 |
Class II
|
Ongoing |
Z-0759-2023 |
Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdomin… |
— |
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. |
| 2022-11-10 |
Class II
|
Ongoing |
Z-0758-2023 |
Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal… |
— |
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. |
| 2022-11-10 |
Class II
|
Ongoing |
Z-0757-2023 |
Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Or… |
— |
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. |
| 2022-11-10 |
Class II
|
Ongoing |
Z-0756-2023 |
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062).… |
— |
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. |
| 2022-11-10 |
Class II
|
Ongoing |
Z-0755-2023 |
Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdomina… |
— |
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. |
| 2022-11-10 |
Class II
|
Ongoing |
Z-0754-2023 |
Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdomina… |
— |
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. |
| 2022-11-10 |
Class II
|
Ongoing |
Z-0753-2023 |
Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small O… |
— |
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. |
| 2022-11-10 |
Class II
|
Ongoing |
Z-0752-2023 |
Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small O… |
— |
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. |
| 2022-10-28 |
Class II
|
Ongoing |
Z-0722-2023 |
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imagin… |
— |
There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies require… |
| 2022-10-28 |
Class II
|
Ongoing |
Z-0721-2023 |
Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and dat… |
— |
There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies require… |