Reported Mar 19, 2025 · Ongoing
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
- Lot codes and dates
21 of 21 products
Products covered by this recall # Barcodes Product as published 1 00195278460271System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN 2 System ID Number 650493REV2, UDI To be provided, Mfg. Lot/Serial Number REVVX1900036CN 3 00195278460271System ID Number 864512APEX1, UDI (01)00195278460271(11)240500(21)REV2X2400059CN, Mfg. Lot/Serial Number REV2X2400059CN 4 00195278460271System ID Number 832325REV, UDI (01)00195278460271(11)241000(21)REV2X2400134CN, Mfg. Lot/Serial Number REV2X2400134CN 5 System ID Number 281MWREVCT, UDI To be provided, Mfg. Lot/Serial Number REVVX1900008CN 6 System ID Number 713792ACT39, UDI To be provided, Mfg. Lot/Serial Number REVV82100006CN 7 System ID Number 206320REV, UDI To be provided, Mfg. Lot/Serial Number 00000441459CN5 8 System ID Number 206320REV2, UDI To be provided, Mfg. Lot/Serial Number REVV82200025CN 9 08242119070100195278633149System ID Number 082421190701, UDI (01)00195278633149(11)241100(21)CBFCG2400026HM, Mfg. Lot/Serial Number CBFCG2400026HM 10 00840682146616System ID Number DK1044CT12, UDI (01)00840682146616(11)200200(21)REV2A2000001CN, Mfg. Lot/Serial Number REV2A2000001CN 11 00840682146616System ID Number DK1547CT02, UDI (01)00840682146616(11)210100(21)REV2A2100002CN, Mfg. Lot/Serial Number REV2A2100002CN 12 System ID Number 11525316, UDI To be provided, Mfg. Lot/Serial Number REV2X2400082CN 13 00195278460271System ID Number 259056CT01, UDI (01)00195278460271(11)230800(21)REV2X2300051CN, Mfg. Lot/Serial Number REV2X2300051CN 14 System ID Number 11437190, UDI To be provided, Mfg. Lot/Serial Number CBGLG2400001HM 15 00195278460271System ID Number 0850211094, UDI (01)00195278460271(11)230800(21)REV2X2300048CN, Mfg. Lot/Serial Number REV2X2300048CN 16 System ID Number 12622329, UDI To be provided, Mfg. Lot/Serial Number REV2X2400165CN 17 System ID Number M001CT06, UDI To be provided, Mfg. Lot/Serial Number Not Available 18 00195278460271System ID Number M004CT02, UDI (01)00195278460271(11)230400(21)REV2X2300005CN, Mfg. Lot/Serial Number REV2X2300005CN 19 00840682123471System ID Number AC002CT05, UDI (01)00840682123471(11)190100(21)REVV81900003CN, Mfg. Lot/Serial Number REVV81900003CN 20 00195278460271System ID Number R002CT12, UDI (01)00195278460271(11)230500(21)REV2X2300012CN, Mfg. Lot/Serial Number REV2X2300012CN - Amount recalled
- 21 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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