Reported Mar 19, 2025 · Ongoing
GE Healthcare Revolution Apex Elite, 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 Apex Elite, System, X-ray, Tomography, Computed
- Lot codes and dates
250 of 250 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 00195278460271System ID Number 256265STCT, UDI (01)00195278460271(11)230600(21)REV2X2300021CN, Mfg. Lot/Serial Number REV2X2300021CN 3 00195278460271System ID Number 480342APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400065CN, Mfg. Lot/Serial Number REV2X2400065CN 4 00195278460271System ID Number 480342APEX3, UDI (01)00195278460271(11)240600(21)REV2X2400067CN, Mfg. Lot/Serial Number REV2X2400067CN 5 00195278460271System ID Number 949250APEX, UDI (01)00195278460271(11)230500(21)REV2X2300008CN, Mfg. Lot/Serial Number REV2X2300008CN 6 00195278460271System ID Number 858824REV, UDI (01)00195278460271(11)241100(21)REV2X2400147CN, Mfg. Lot/Serial Number REV2X2400147CN 7 00195278460271System ID Number 707257APEX1, UDI (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/Serial Number REV2X2300077CN 8 00195278460271System ID Number 714456APEX, UDI (01)00195278460271(11)231200(21)REV2X2300094CN, Mfg. Lot/Serial Number REV2X2300094CN 9 00195278460271System ID Number 719227APEX1, UDI (01)00195278460271(11)240200(21)REV2X2400019CN, Mfg. Lot/Serial Number REV2X2400019CN 10 00195278460271System ID Number 970945CT, UDI (01)00195278460271(11)240400(21)REV2X2400046CN, Mfg. Lot/Serial Number REV2X2400046CN 11 00195278460271System ID Number 203576EDAPEX, UDI (01)00195278460271(11)240300(21)REV2X2400021CN, Mfg. Lot/Serial Number REV2X2400021CN 12 00195278460271System ID Number 860224EDAPEX, UDI (01)00195278460271(11)240500(21)REV2X2400050CN, Mfg. Lot/Serial Number REV2X2400050CN 13 00195278460271System ID Number 203276APEX1, UDI (01)00195278460271(11)240800(21)REV2X2400095CN, Mfg. Lot/Serial Number REV2X2400095CN 14 00195278460271System ID Number 302744APEX, UDI (01)00195278460271(11)240600(21)REV2X2400078CN, Mfg. Lot/Serial Number REV2X2400078CN 15 00195278460271System ID Number 561737APEX1, UDI (01)00195278460271(11)240900(21)REV2X2400114CN, Mfg. Lot/Serial Number REV2X2400114CN 16 00195278460271System ID Number 561737APEX2, UDI (01)00195278460271(11)240900(21)REV2X2400112CN, Mfg. Lot/Serial Number REV2X2400112CN 17 00195278460271System ID Number 786243APEX1, UDI (01)00195278460271(11)230900(21)REV2X2300059CN, Mfg. Lot/Serial Number REV2X2300059CN 18 00195278460271System ID Number 305323APEX, UDI (01)00195278460271(11)240900(21)REV2X2400123CN, Mfg. Lot/Serial Number REV2X2400123CN 19 00195278460271System ID Number 904UFNAPEX, UDI (01)00195278460271(11)230300(21)REV2X2300001CN, Mfg. Lot/Serial Number REV2X2300001CN 20 00195278460271System ID Number 863680APEX, UDI (01)00195278460271(11)230900(21)REV2X2300057CN, Mfg. Lot/Serial Number REV2X2300057CN - Amount recalled
- 250 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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