FDA Device recall Z-1303-2025
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
- FDA Device
- Class II
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class II recall of GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed by Ge Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1303-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-18 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems |
| Distribution | n/a |
Product
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
Reason
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.
Identifiers
| code_info | System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN…System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number 650493REV2, UDI To be provided, Mfg. Lot/Serial Number REVVX1900036CN; System ID Number 864512APEX1, UDI (01)00195278460271(11)240500(21)REV2X2400059CN, Mfg. Lot/Serial Number REV2X2400059CN; System ID Number 832325REV, UDI (01)00195278460271(11)241000(21)REV2X2400134CN, Mfg. Lot/Serial Number REV2X2400134CN; System ID Number 281MWREVCT, UDI To be provided, Mfg. Lot/Serial Number REVVX1900008CN; System ID Number 713792ACT39, UDI To be provided, Mfg. Lot/Serial Number REVV82100006CN; System ID Number 206320REV, UDI To be provided, Mfg. Lot/Serial Number 00000441459CN5; System ID Number 206320REV2, UDI To be provided, Mfg. Lot/Serial Number REVV82200025CN; System ID Number 082421190701, UDI (01)00195278633149(11)241100(21)CBFCG2400026HM, Mfg. Lot/Serial Number CBFCG2400026HM; System ID Number DK1044CT12, UDI (01)00840682146616(11)200200(21)REV |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1303-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.