FDA Medical devices recall ·
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed recall
- Recall number
- Z-1297-2025
- Date
- (initiated February 18, 2025)
- Company / brand
- GE Medical Systems, LLC
3000 N Grandview Blvd, Waukesha, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 56 units
- Hazard tags
- Fall Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
System ID Number: 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number: 650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN; System ID Number: 630266CTRV, UDI (01)00195278460271(11)240800(21)REV2X2400093CN, Mfg. Lot/Serial Number REV2X2400093CN; System ID Number: 773702REVCT6ED, UDI (01)00195278460271(11)231000(21)REV2X2300071CN, Mfg. Lot/Serial Number REV2X2300071CN; System ID Number: 312996CTRV2, UDI (01)00195278460271(11)241000(21)REV2X2400126CN, Mfg. Lot/Serial Number REV2X2400126CN; System ID Number: 1000000018, UDI To be provided, Mfg. Lot/Serial Number REV2X2300074CN; System ID Number: 617726Y6REV2, UDI (01)00840682118552(11)170900(21)REVVX1700090CN, Mfg. Lot/Serial Number REVVX1700090CN; System ID Number: 617726Y6REV1, UDI (01)00840682118552(11)160700(21)REVVX1600018CN, Mfg. Lot/Serial Number REVVX1600018CN; System ID Number: 336890APEX, UDI (01)00195278460271(11)240900(21)REV2X2400116CN, Mfg. Lot/Serial Number REV2X2400116CN; System ID Number: 704801APEX, UDI (01)00195278460271(11)241000(21)REV2X2400139CN, Mfg. Lot/Serial Number REV2X2400139CN; System ID Number: 336832APEX, UDI (01)00195278460271(11)241000(21)REV2X2400129CN, Mfg. Lot/Serial Number REV2X2400129CN; System ID Number: 980993CT1, UDI (01)00840682146616(11)210700(21)REV2A2100029CN, Mfg. Lot/Serial Number REV2A2100029CN; System ID Number: 910715REV1, UDI (01)00195278460271(11)241200(21)REV2X2400155CN, Mfg. Lot/Serial Numbe
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1297-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.