GE Healthcare Revolution Apex — Class II medical device recall Z-1297-2025
Ongoing recall by GE Medical Systems, LLC, reported 2025-03-19. GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT sys
| Recall number | Z-1297-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2025-02-18 |
| Classified | 2025-03-07 |
| Reported by FDA | 2025-03-19 |
| Quantity | 56 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00195278460271, 00195278469700, 00195278633149, 00840682118552, 00840682123471, 00840682146616 |
| Serial numbers | 00000441066CN8, 00000442334CN9, 00000442412CN3, CBFCG2400004HM, CBFCG2400006HM, REV242200004CN, REV2A2000001CN, REV2A2100019CN, REV2A2100029CN, REV2A2200006CN, REV2A2200007CN, REV2X23000030CN, REV2X2300016CN, REV2X2300026CN, REV2X2300046CN, REV2X2300050CN, REV2X2300071CN, REV2X2300074CN, REV2X2300075CN, REV2X2300079CN, REV2X2300081CN, REV2X2300082CN, REV2X2300087CN, REV2X2400014CN, REV2X2400017CN and 28 more |
Product
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Reason for recall
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1297-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.