Reported Mar 19, 2025 · Ongoing
GE Healthcare Revolution Apex Expert, 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 Expert, System, X-ray, Tomography, Computed
- Lot codes and dates
42 of 42 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 00840682123471System ID Number 205608CT, UDI (01)00840682123471(11)180800(21)REVV81800010CN, Mfg. Lot/Serial Number REVV81800010CN 3 00195278460271System ID Number 256265STCT, UDI (01)00195278460271(11)230600(21)REV2X2300021CN, Mfg. Lot/Serial Number REV2X2300021CN 4 System ID Number 205699CTREV, UDI Not Applicable, Mfg. Lot/Serial Number 00000442592CN2 5 00840682146616System ID Number 480342APEX, UDI (01)00840682146616(11)220900(21)REV2A2200072CN, Mfg. Lot/Serial Number REV2A2200072CN 6 00195278460271System ID Number 480342APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400065CN, Mfg. Lot/Serial Number REV2X2400065CN 7 00195278460271System ID Number 480342APEX3, UDI (01)00195278460271(11)240600(21)REV2X2400067CN, Mfg. Lot/Serial Number REV2X2400067CN 8 System ID Number 11320, UDI To be provided, Mfg. Lot/Serial Number REVVX2000033CN 9 00195278460271System ID Number 949250APEX, UDI (01)00195278460271(11)230500(21)REV2X2300008CN, Mfg. Lot/Serial Number REV2X2300008CN 10 00840682118552System ID Number 858657APEX, UDI (01)00840682118552(11)160900(21)REVVX1600034CN, Mfg. Lot/Serial Number REVVX1600034CN 11 00195278460271System ID Number 858824REV, UDI (01)00195278460271(11)241100(21)REV2X2400147CN, Mfg. Lot/Serial Number REV2X2400147CN 12 System ID Number 858824APEX, UDI Not Applicable, Mfg. Lot/Serial Number 00000443327CN2 13 00840682118552System ID Number 310423CT, UDI (01)00840682118552(11)211200(21)REVVX2100047CN, Mfg. Lot/Serial Number REVVX2100047CN 14 00195278460271System ID Number 707257APEX1, UDI (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/Serial Number REV2X2300077CN 15 00195278460271System ID Number 714456APEX, UDI (01)00195278460271(11)231200(21)REV2X2300094CN, Mfg. Lot/Serial Number REV2X2300094CN 16 System ID Number 650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN 17 System ID Number 650493REV2, UDI To be provided, Mfg. Lot/Serial Number REVVX1900036CN 18 00840682146616System ID Number 818708CTWSO, UDI (01)00840682146616(11)220900(21)REV2A2200065CN, Mfg. Lot/Serial Number REV2A2200065CN 19 System ID Number 310222REVO, UDI Not Applicable, Mfg. Lot/Serial Number 00000445059CN9 20 00195278460271System ID Number 719227APEX1, UDI (01)00195278460271(11)240200(21)REV2X2400019CN, Mfg. Lot/Serial Number REV2X2400019CN - Amount recalled
- 42 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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