Ge Healthcare China recalls
Ge Healthcare China appears in 24 official U.S. recall notices indexed by RecallRadar, most recently on 2025-03-05.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 24 |
|---|---|
| Published | 2024-09-04 to 2025-03-05 |
| By agency | FDA Device (24) |
| By classification | Class II (24) |
| By status | ongoing (24) |
| Distribution named in notices | US |
Recalls
- SIGNA MR355, SIGNA MR360, NMRI system
FDA Device · Class II · 2025-03-05 · Ge Healthcare China
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… - SIGNA MR380, NMRI system, Non-US Only
FDA Device · Class II · 2025-03-05 · Ge Healthcare China
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… - Optima MR360, NMRI system
FDA Device · Class II · 2025-03-05 · Ge Healthcare China
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… - SIGNA Creator, SIGNA Explorer, NMRI systems
FDA Device · Class II · 2025-03-05 · Ge Healthcare China
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… - Brivo MR355, NMRI system
FDA Device · Class II · 2025-03-05 · Ge Healthcare China
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… - GE Healthcare Revolution Ascend Elite, Model Number 6967000-100
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Eli…
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Revolution Maxima M, Model Number, 6670000-2
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580,…
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Revolution ACE, Model number 6670000-3
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Optima 680 Expert, Model number 6670000
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Optima 520, Catalog number 5439126
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Revolution EVO, Model Number 5454001-260
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Revolution Maxima Select, Model Number, 6670000-55
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Revolution Advance, Model number 5849504
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Healthcare Revolution Ascend, Model number 6969000-100
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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… - GE Proteus XR/A radiographic system
FDA Device · Class II · 2024-12-04 · Ge Healthcare China
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. - GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973
FDA Device · Class II · 2024-09-04 · Ge Healthcare China
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…