FDA Enforcement History: GE Healthcare GmbH

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. GE Healthcare GmbH has 3 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.

Enforcement history

On 2025-12-24, Argus HQ recorded an FDA recall for GE Healthcare GmbH, rated "high" severity in Argus HQ's classification: GE Healthcare GmbH — Class II recall: GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processin…. On 2024-09-25, Argus HQ recorded an FDA recall for GE Healthcare GmbH, rated "high" severity in Argus HQ's classification: GE Healthcare GmbH — Class II recall: ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE,…. On 2024-09-25, Argus HQ recorded an FDA recall for GE Healthcare GmbH, rated "high" severity in Argus HQ's classification: GE Healthcare GmbH — Class II recall: ViewPoint; system, imaging processing, radiological. 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. 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. 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. 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.

Frequently asked questions

What is the most recent FDA action against GE Healthcare GmbH?

The most recent FDA event Argus HQ has on file for GE Healthcare GmbH is dated 2025-12-24, 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 GmbH 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 GmbH is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for GE Healthcare GmbH?

3 total: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for GE Healthcare GmbH?

December 24, 2025. Argus HQ ingests new FDA enforcement records daily.

Related enforcement actions

• GE Healthcare GmbH — Class II recall: GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processin… →
• GE Healthcare GmbH — Class II recall: ViewPoint; system, imaging processing, radiological →
• GE Healthcare GmbH — Class II recall: ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE,… →

Compare with

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