GE HEALTHCARE AUSTRIA GMBH & CO FDA Record
- No warning letters matched by name
GE HEALTHCARE AUSTRIA GMBH & CO has 1 FDA recall, 0 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "GE HEALTHCARE AUSTRIA GMBH & CO" is on file.
- Latest recall
- Z-3171-2026 · Jul 31, 2026 · filed under Ge Healthcare
- Latest recall under this name
- Z-0865-2024 · Class II · Dec 22, 2023
Newer recall under related name Ge Healthcare: Jul 31, 2026, Z-3171-2026.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing GE HEALTHCARE AUSTRIA GMBH & CO as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check GE HEALTHCARE AUSTRIA GMBH & CO yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0865-2024 | Class II | GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and… | Dec 22, 2023 |
GE HEALTHCARE AUSTRIA GMBH & CO and the FDA: common questions
Has GE HEALTHCARE AUSTRIA GMBH & CO received an FDA warning letter?
No FDA warning letter addressed to the name "GE HEALTHCARE AUSTRIA GMBH & CO" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has GE HEALTHCARE AUSTRIA GMBH & CO received an FDA Form 483?
FDA has not published a Form 483 for "GE HEALTHCARE AUSTRIA GMBH & CO" in its reading room. FDA publishes some Form 483s, not all of them.
Has GE HEALTHCARE AUSTRIA GMBH & CO had an FDA recall?
Yes. GE HEALTHCARE AUSTRIA GMBH & CO has 1 FDA recall on record. The most recent under this name started Dec 22, 2023. A newer recall, dated Jul 31, 2026, is filed under the related name Ge Healthcare.
Need more than this page shows? Ask about GE HEALTHCARE AUSTRIA GMBH & CO in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.