Reported Mar 19, 2025 · Ongoing
GE Healthcare Revolution CT, 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, System, X-ray, Tomography, Computed
- Lot codes and dates
105 of 105 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 00840682146616System ID Number 480342APEX, UDI (01)00840682146616(11)220900(21)REV2A2200072CN, Mfg. Lot/Serial Number REV2A2200072CN 3 00195278460271System ID Number 480342APEX3, UDI (01)00195278460271(11)240600(21)REV2X2400067CN, Mfg. Lot/Serial Number REV2X2400067CN 4 00195278460271System ID Number 949250APEX, UDI (01)00195278460271(11)230500(21)REV2X2300008CN, Mfg. Lot/Serial Number REV2X2300008CN 5 00840682118552System ID Number 858657APEX, UDI (01)00840682118552(11)160900(21)REVVX1600034CN, Mfg. Lot/Serial Number REVVX1600034CN 6 00840682118552System ID Number 310423CT, UDI (01)00840682118552(11)211200(21)REVVX2100047CN, Mfg. Lot/Serial Number REVVX2100047CN 7 00195278460271System ID Number 707257APEX1, UDI (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/Serial Number REV2X2300077CN 8 System ID Number 650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN 9 System ID Number 408559CTREVO, UDI To be provided, Mfg. Lot/Serial Number REVV81900011CN 10 00195278460271System ID Number 904UFNAPEX, UDI (01)00195278460271(11)230300(21)REV2X2300001CN, Mfg. Lot/Serial Number REV2X2300001CN 11 00195278460271System ID Number 813972APEX2, UDI (01)00195278460271(11)240700(21)REV2X2400088CN, Mfg. Lot/Serial Number REV2X2400088CN 12 00195278460271System ID Number 813972APEX3, UDI (01)00195278460271(11)241000(21)REV2X2400135CN, Mfg. Lot/Serial Number REV2X2400135CN 13 System ID Number 808522RCT, UDI Not Applicable, Mfg. Lot/Serial Number 00000441716CN8 14 00195278460271System ID Number 312996CTRV2, UDI (01)00195278460271(11)241000(21)REV2X2400126CN, Mfg. Lot/Serial Number REV2X2400126CN 15 00195278460271System ID Number 708245APEX1, UDI (01)00195278460271(11)230900(21)REV2X2300064CN, Mfg. Lot/Serial Number REV2X2300064CN 16 00840682146616System ID Number 718334CTREV, UDI (01)00840682146616(11)220700(21)REV2A2200050CN, Mfg. Lot/Serial Number REV2A2200050CN 17 00195278502179System ID Number 765298APEX2, UDI (01)00195278502179(11)241000(21)REV282400043CN, Mfg. Lot/Serial Number REV282400043CN 18 00195278460271System ID Number 913588APEX2, UDI (01)00195278460271(11)231200(21)REV2X2300091CN, Mfg. Lot/Serial Number REV2X2300091CN 19 System ID Number 270444APEXCT, UDI To be provided, Mfg. Lot/Serial Number REV2X2300083CN 20 00195278460271System ID Number 508971REV, UDI (01)00195278460271(11)241000(21)REV2X2400124CN, Mfg. Lot/Serial Number REV2X2400124CN - Amount recalled
- 105 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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