GE Healthcare (China) Co., Ltd. recall records

24 reported ongoing

24 records in this archive. Latest source date Jan 31, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

SIGNA Creator, SIGNA Explorer, NMRI systems

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 ...

Class IIReported ongoing

Distribution: Domestic US distribution nationwide. International distribution worldwide.

Official source for SIGNA Creator, SIGNA Explorer, NMRI systems
FDA device enforcement

Brivo MR355, NMRI system

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 ...

Class IIReported ongoing

Distribution: Domestic US distribution nationwide. International distribution worldwide.

Official source for Brivo MR355, NMRI system
FDA device enforcement

Optima MR360, NMRI system

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 ...

Class IIReported ongoing

Distribution: Domestic US distribution nationwide. International distribution worldwide.

Official source for Optima MR360, NMRI system
FDA device enforcement

SIGNA MR355, SIGNA MR360, NMRI system

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 ...

Class IIReported ongoing

Distribution: Domestic US distribution nationwide. International distribution worldwide.

Official source for SIGNA MR355, SIGNA MR360, NMRI system
FDA device enforcement

SIGNA MR380, NMRI system, Non-US Only

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 ...

Class IIReported ongoing

Distribution: Domestic US distribution nationwide. International distribution worldwide.

Official source for SIGNA MR380, NMRI system, Non-US Only
FDA device enforcement

GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
FDA device enforcement

GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
FDA device enforcement

GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
FDA device enforcement

GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
FDA device enforcement

GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
FDA device enforcement

GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
FDA device enforcement

GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
FDA device enforcement

GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
FDA device enforcement

GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
FDA device enforcement

GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomo...
FDA device enforcement

GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 66...
FDA device enforcement

GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
FDA device enforcement

GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
FDA device enforcement

GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed ...

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Pac...
FDA device enforcement

GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite,...

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 mod...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Conso...

Reasons in these listed records

  • 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...
  • 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 ...

These examples come from this result page and are not a ranking of every recall reason.

Checking GE Healthcare (China) Co., Ltd.

Is there a recall on ge healthcare (china) co., ltd. right now?

This archive contains 24 records, including 24 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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