Beijing, China
GE Healthcare (China) Co., Ltd. recalls
4 recalls recorded since 2018, most recently on 31 January 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)4
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 31 January 2025
- Reason
- For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
- Distribution
- Domestic US distribution nationwide. International distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1240-2025, Z-1239-2025, Z-1242-2025, Z-1243-2025, Z-1241-2025
- Brivo MR355, NMRI system
- SIGNA Creator, SIGNA Explorer, NMRI systems
- SIGNA MR355, SIGNA MR360, NMRI system
- SIGNA MR380, NMRI system, Non-US Only
- Optima MR360, NMRI system
Ongoing Class II Medical devices
- Recall started
- 5 November 2024
- Reason
- GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0603-2025, Z-0602-2025, Z-0607-2025, Z-0600-2025, Z-0609-2025, Z-0604-2025, Z-0612-2025, Z-0614-2025, Z-0606-2025, Z-0605-2025, Z-0611-2025, Z-0608-2025 and 5 more
- GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
- GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
- GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
- GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
- GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
- GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
- GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
- GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite, BrightSpeed Elite Select; X-ray/c
- and 9 more product lines
Ongoing Class II Medical devices
- Recall started
- 24 October 2024
- Reason
- Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0550-2025
- GE Proteus XR/A radiographic system
Ongoing Class II Medical devices
- Recall started
- 12 July 2024
- Reason
- The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2733-2024
- GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 22599
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.