Regulatory Record: GE HEALTHCARE AUSTRIA GMBH & CO

FDA action counts

Enforcement history

On 2024-02-07, Argus HQ recorded an FDA recall for GE HEALTHCARE AUSTRIA GMBH & CO, rated "high" severity in Argus HQ's classification: GE HEALTHCARE AUSTRIA GMBH & CO — Class II recall: GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultra…. 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. GE HEALTHCARE AUSTRIA GMBH & CO has 1 FDA event on file. 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

What is the most recent FDA action on file for GE HEALTHCARE AUSTRIA GMBH & CO?

February 7, 2024. Argus HQ ingests new FDA enforcement records daily.

Has GE HEALTHCARE AUSTRIA GMBH & CO had product recalls?

Yes, 1 recall on file. See the full history below for each one.

Is this FDA enforcement data for GE HEALTHCARE AUSTRIA GMBH & CO official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has GE HEALTHCARE AUSTRIA GMBH & CO had?

Argus HQ has recorded 1 FDA events for GE HEALTHCARE AUSTRIA GMBH & CO: 0 warning letters, 1 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.

Related enforcement actions

• GE HEALTHCARE AUSTRIA GMBH & CO — Class II recall: GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultra… →

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