Recall Z-1303-2025 ยท JAK System, X-Ray, Tomography, Computed
GE Medical Systems, LLC
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
| Date | Mar 7, 2025 (initiated Feb 18, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process change control |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/18/2025 via letter delivered using a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken: "You can continue to use your system. Please monitor the floor near the base of the gantry for any accumulation of blue fluid. If blue fluid is observed, wear nitrile or rubber gloves, clean up the fluid by absorbing it with a noncombustible absorbent material, and dispose of the absorbent material in a suitable container for disposal. Please contact your local |
| Quantity | 21 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163213 | Revolution CT Ge Medical Systems, LLC, Dec 16, 2016 |
| K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition Ge Medical Systems, LLC, Jul 26, 2019 |
| K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Re Ge Medical Systems, LLC, Dec 17, 2021 |