How many FDA actions has GE Healthcare (China) Co., Ltd. had?

Argus HQ has recorded 24 FDA events for GE Healthcare (China) Co., Ltd.: 0 warning letters, 24 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against GE Healthcare (China) Co., Ltd.?

The most recent FDA event Argus HQ has on file for GE Healthcare (China) Co., Ltd. is dated 2025-03-05, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for GE Healthcare (China) Co., Ltd. automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to GE Healthcare (China) Co., Ltd. is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for GE Healthcare (China) Co., Ltd.?

24 total: 0 warning letters, 24 recalls, 0 approval records, and 0 Form 483 inspection citations.

Regulatory Record: GE Healthcare (China) Co., Ltd.

FDA action counts

Total FDA actions	24
Warning letters	0
Recalls	24
Approval records	0
Form 483 inspection citations	0
Most recent action	March 5, 2025

The short version: Argus HQ has recorded 24 FDA events for GE Healthcare (China) Co., Ltd.: 0 warning letters, 24 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2024-09-04 to 2025-03-05. The most severe rating Argus HQ has assigned across this history is "high". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Enforcement history

On 2025-03-05, Argus HQ recorded an FDA recall for GE Healthcare (China) Co., Ltd., rated "high" severity in Argus HQ's classification: GE Healthcare (China) Co., Ltd. — Class II recall: Optima MR360, NMRI system. On 2025-03-05, Argus HQ recorded an FDA recall for GE Healthcare (China) Co., Ltd., rated "high" severity in Argus HQ's classification: GE Healthcare (China) Co., Ltd. — Class II recall: Brivo MR355, NMRI system. On 2025-03-05, Argus HQ recorded an FDA recall for GE Healthcare (China) Co., Ltd., rated "high" severity in Argus HQ's classification: GE Healthcare (China) Co., Ltd. — Class II recall: SIGNA MR380, NMRI system, Non-US Only. On 2025-03-05, Argus HQ recorded an FDA recall for GE Healthcare (China) Co., Ltd., rated "high" severity in Argus HQ's classification: GE Healthcare (China) Co., Ltd. — Class II recall: SIGNA Creator, SIGNA Explorer, NMRI systems. On 2025-03-05, Argus HQ recorded an FDA recall for GE Healthcare (China) Co., Ltd., rated "high" severity in Argus HQ's classification: GE Healthcare (China) Co., Ltd. — Class II recall: SIGNA MR355, SIGNA MR360, NMRI system. On 2024-12-11, Argus HQ recorded an FDA recall for GE Healthcare (China) Co., Ltd., rated "high" severity in Argus HQ's classification: GE Healthcare (China) Co., Ltd. — Class II recall: GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA:…. On 2024-12-11, Argus HQ recorded an FDA recall for GE Healthcare (China) Co., Ltd., rated "high" severity in Argus HQ's classification: GE Healthcare (China) Co., Ltd. — Class II recall: GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009;…. On 2024-12-11, Argus HQ recorded an FDA recall for GE Healthcare (China) Co., Ltd., rated "high" severity in Argus HQ's classification: GE Healthcare (China) Co., Ltd. — Class II recall: GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomo…. On 2024-12-11, Argus HQ recorded an FDA recall for GE Healthcare (China) Co., Ltd., rated "high" severity in Argus HQ's classification: GE Healthcare (China) Co., Ltd. — Class II recall: GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography…. On 2024-12-11, Argus HQ recorded an FDA recall for GE Healthcare (China) Co., Ltd., rated "high" severity in Argus HQ's classification: GE Healthcare (China) Co., Ltd. — Class II recall: GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA:…. On 2024-12-11, Argus HQ recorded an FDA recall for GE Healthcare (China) Co., Ltd., rated "high" severity in Argus HQ's classification: GE Healthcare (China) Co., Ltd. — Class II recall: GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography…. On 2024-12-11, Argus HQ recorded an FDA recall for GE Healthcare (China) Co., Ltd., rated "high" severity in Argus HQ's classification: GE Healthcare (China) Co., Ltd. — Class II recall: GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA:….

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. GE Healthcare (China) Co., Ltd. has 24 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Frequently asked questions

How many FDA actions has GE Healthcare (China) Co., Ltd. had?: Argus HQ has recorded 24 FDA events for GE Healthcare (China) Co., Ltd.: 0 warning letters, 24 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
What is the most recent FDA action against GE Healthcare (China) Co., Ltd.?: The most recent FDA event Argus HQ has on file for GE Healthcare (China) Co., Ltd. is dated 2025-03-05, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Does Argus HQ track new FDA actions for GE Healthcare (China) Co., Ltd. automatically?: Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to GE Healthcare (China) Co., Ltd. is observed, this page's event count and history update automatically.
How many FDA actions does Argus HQ track for GE Healthcare (China) Co., Ltd.?: 24 total: 0 warning letters, 24 recalls, 0 approval records, and 0 Form 483 inspection citations.

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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Verified from FDA.gov · Last updated: Mar 5, 2025

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2025). Regulatory Record: GE Healthcare (China) Co., Ltd.. Digital Empire LLC. Retrieved from https://argushq.ai/company/ge-healthcare-china-co-ltd

MLA

"Regulatory Record: GE Healthcare (China) Co., Ltd.." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/company/ge-healthcare-china-co-ltd.

Chicago

Argus HQ Research. "Regulatory Record: GE Healthcare (China) Co., Ltd.." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/company/ge-healthcare-china-co-ltd.

BibTeX

@misc{argushq_argushq_ai_company_ge_healthcare_china_co_ltd_2025,
  title = {Regulatory Record: GE Healthcare (China) Co., Ltd.},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/ge-healthcare-china-co-ltd},
  note = {Accessed: July 17, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗