Drug & Device Safety Atlas

FDA recall record · openFDA

GE Healthcare (China) Co., Ltd.

24 FDA recalls on record (2024–2025) — 24 device. 24 still ongoing.

0
Class I (most serious)
24
Class II
0
Class III
24
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and cert 17
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above th 5
The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devic 1
Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the 1

Recalls

Brivo MR355, NMRI system Class II 2025-01-31 SIGNA Creator, SIGNA Explorer, NMRI systems Class II 2025-01-31 SIGNA MR355, SIGNA MR360, NMRI system Class II 2025-01-31 SIGNA MR380, NMRI system, Non-US Only Class II 2025-01-31 Optima MR360, NMRI system Class II 2025-01-31 GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems Class II 2024-11-05 GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system Class II 2024-11-05 GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system Class II 2024-11-05 GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as: Class II 2024-11-05 GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system Class II 2024-11-05 GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems Class II 2024-11-05 GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; Class II 2024-07-12 GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system Class II 2024-11-05 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Class II 2024-11-05 GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system Class II 2024-11-05 GE Proteus XR/A radiographic system Class II 2024-10-24 GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system Class II 2024-11-05 GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system Class II 2024-11-05 GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system Class II 2024-11-05 GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems Class II 2024-11-05 GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-r Class II 2024-11-05 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD Class II 2024-11-05 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT Class II 2024-11-05 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Disc Class II 2024-11-05

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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