GE Healthcare (China) Co., Ltd. FDA Recalls

24 recalls on file across devices, 0 of them Class I and 24 still open. Matched by name to GEHC.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Related datasets

FDA ApprovalsNew drugs approved, and devices cleared for sale.Workplace SafetyOSHA inspections and citations, by company.Congress TradingThe live feed of disclosed transactions.Politician SearchEvery member who files, and what they hold.

Product	Reason	Class	Initiated
SIGNA MR355, SIGNA MR360, NMRI systemClass IIJan 31, 2025For certain MR systems, a scan can be resumed following a Po	For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" i	Class IIDevices	Jan 31, 2025
SIGNA MR380, NMRI system, Non-US OnlyClass IIJan 31, 2025For certain MR systems, a scan can be resumed following a Po	For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" i	Class IIDevices	Jan 31, 2025
Brivo MR355, NMRI systemClass IIJan 31, 2025For certain MR systems, a scan can be resumed following a Po	For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" i	Class IIDevices	Jan 31, 2025
SIGNA Creator, SIGNA Explorer, NMRI systemsClass IIJan 31, 2025For certain MR systems, a scan can be resumed following a Po	For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" i	Class IIDevices	Jan 31, 2025
Optima MR360, NMRI systemClass IIJan 31, 2025For certain MR systems, a scan can be resumed following a Po	For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" i	Class IIDevices	Jan 31, 2025
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography systemClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:Class IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography systemClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography systemClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography systemClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-rClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed,Class IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systemsClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CTClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography systemClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography systemClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systemsClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HDClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: DiscClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systemsClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography systemClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography systemClass IINov 5, 2024GE HealthCare has become aware of a potential issue on certa	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems	Class IIDevices	Nov 5, 2024
GE Proteus XR/A radiographic systemClass IIOct 24, 2024Steel cables in the Wall Stand for certain Proteus XR/a syst	Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replac	Class IIDevices	Oct 24, 2024
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; Class IIJul 12, 2024The XR system, Proteus XR/a, does not have a de-installation	The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing	Class IIDevices	Jul 12, 2024