Recall archive / FDA device enforcement
GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed — FDA record Z-1300-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 4 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1300-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Mar 19, 2025
- Recall initiation date
- Feb 18, 2025
- Center classification date
- Mar 7, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.