GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
FDA Device Recall #Z-1303-2025 — Class II — February 18, 2025
Recall Summary
| Recall Number | Z-1303-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 18, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 21 units |
Product Description
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
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 for injury if the fluid is not noticed and a person slips and/or falls.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
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)REV2A2000001CN, Mfg. Lot/Serial Number REV2A2000001CN; System ID Number DK1547CT02, UDI (01)00840682146616(11)210100(21)REV2A2100002CN, Mfg. Lot/Serial Number REV2A2100002CN; System ID Number 11525316, UDI To be provided, Mfg. Lot/Serial Number REV2X2400082CN; System ID Number 259056CT01, UDI (01)00195278460271(11)230800(21)REV2X2300051CN, Mfg. Lot/Serial Number REV2X2300051CN; System ID Number 11437190, UDI To be provided, Mfg. Lot/Serial Number CBGLG2400001HM; System ID Number 0850211094, UDI (01)00195278460271(11)230800(21)REV2X2300048CN, Mfg. Lot/Serial Number REV2X2300048CN; System ID Number 12622329, UDI To be provided, Mfg. Lot/Serial Number REV2X2400165CN; System ID Number M001CT06, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number M004CT02, UDI (01)00195278460271(11)230400(21)REV2X2300005CN, Mfg. Lot/Serial Number REV2X2300005CN; System ID Number AC002CT05, UDI (01)00840682123471(11)190100(21)REVV81900003CN, Mfg. Lot/Serial Number REVV81900003CN; System ID Number R002CT12, UDI (01)00195278460271(11)230500(21)REV2X2300012CN, Mfg. Lot/Serial Number REV2X2300012CN; System ID Number AC001CT05, UDI (01)00840682118552(11)181000(21)REVVX1800101CN, Mfg. Lot/Serial Number REVVX1800101CN
Other Recalls from GE Medical Systems, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2154-2026 | Class II | Revolution Apex, X-ray Computed Tomography, Mod... | Mar 26, 2026 |
| Z-2153-2026 | Class II | Revolution CT ES, X-ray Computed Tomography, Mo... | Mar 26, 2026 |
| Z-2149-2026 | Class II | Revolution Ascend, computed tomography, Model N... | Mar 26, 2026 |
| Z-2151-2026 | Class II | Revolution Apex Elite, X-ray Computed Tomograph... | Mar 26, 2026 |
| Z-2150-2026 | Class II | Revolution CT, x-ray computed tomography, Model... | Mar 26, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.