GE Medical Systems, LLC: GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. Quantity: 250 units Lot/code info: System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number 256265STCT, UDI (01)00195278460271(11)230600(21)REV2X2300021CN, Mfg. Lot/Serial Number REV2X2300021CN; System ID Number 480342APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400065CN, Mfg. Lot/Serial Number REV2X2400065CN; System ID Number 480342APEX3, UDI (01)00195278460271(11)240600(21)REV2X2400067CN, Mfg. Lot/Serial Number REV2X2400067CN; System ID Number 949250APEX, UDI (01)00195278460271(11)230500(21)REV2X2300008CN, Mfg. Lot/Serial Number REV2X2300008CN; System ID Number 858824REV, UDI (01)00195278460271(11)241100(21)REV2X2400147CN, Mfg. Lot/Serial Number REV2X2400147CN; System ID Number 707257APEX1, UDI (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/Serial Number REV2X2300077CN; System ID Number 714456APEX, UDI (01)00195278460271(11)231200(21)REV2X2300094CN, Mfg. Lot/Serial Number REV2X2300094CN; System ID Number 719227APEX1, UDI (01)00195278460271(11)240200(21)REV2X2400019CN, Mfg. Lot/Serial Number REV2X2400019CN; System ID Number 970945CT, UDI (01)00195278460271(11)240400(21)REV2X2400046CN, Mfg. Lot/Serial Number REV2X2400046CN; System ID Number 203576EDAPEX, UDI (01)00195278460271(11)240300(21)REV2X2400021CN, Mfg. Lot/Serial Number REV2X2400021CN; System ID Number 860224EDAPEX, UDI (01)00195278460271(11)240500(21)REV2X2400050CN, Mfg. Lot/Serial Number REV2X2400050CN; System ID Number 203276APEX1, UDI (01)00195278460271(1

UPC codes

00195278460271

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.