Food, drugs, devices › GE Medical Systems, LLC
Device recall: GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
GE Medical Systems, LLC (Waukesha, WI) initiated this device recall on 18 Feb 2025; FDA lists 7 product records under event 96370, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. GE Medical Systems, LLC has 42 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Medical Systems, LLC, Waukesha, WI.
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…"
Distribution
"Worldwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1297-2025 | GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed | 56 units | Class II | Ongoing | 19 Mar 2025 |
| Z-1298-2025 | GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed | 250 units | Class II | Ongoing | 19 Mar 2025 |
| Z-1299-2025 | GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed | 42 units | Class II | Ongoing | 19 Mar 2025 |
| Z-1300-2025 | GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed | 4 units | Class II | Ongoing | 19 Mar 2025 |
| Z-1301-2025 | GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed | 1 unit | Class II | Ongoing | 19 Mar 2025 |
| Z-1302-2025 | GE Healthcare Revolution CT, System, X-ray, Tomography, Computed | 105 units | Class II | Ongoing | 19 Mar 2025 |
| Z-1303-2025 | GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed | 21 units | Class II | Ongoing | 19 Mar 2025 |
Context
Other enforcement events for GE Medical Systems, LLC
All 42 events for GE Medical Systems, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.