FDA Device recall Z-1300-2025
GE Healthcare Revolution Apex Plus, 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 Apex Plus, 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-1300-2025 |
| 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 Apex Plus, 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 336832APEX, UDI (01)00195278460271(11)241000(21)REV2X2400129CN, Mfg. Lot/Serial Number REV2X2400129CN; System ID Number 973971CTREV, UDI (01)00840682118552(11)160600(21)REVVX1600010CN, Mfg. Lot/Serial Number REVVX1600010CN; System ID Number 513584APEX1, UDI (01)00840682146616(11)230300(21)REV2A2300023CN, Mfg. Lot/Serial Number REV2A2300023CN |
|---|
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-1300-2025%22
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