GE Medical Systems, LLC: GE Healthcare Revolution Apex Expert, 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: 42 units Lot/code info: System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number 205608CT, UDI (01)00840682123471(11)180800(21)REVV81800010CN, Mfg. Lot/Serial Number REVV81800010CN; System ID Number 256265STCT, UDI (01)00195278460271(11)230600(21)REV2X2300021CN, Mfg. Lot/Serial Number REV2X2300021CN; System ID Number 205699CTREV, UDI Not Applicable, Mfg. Lot/Serial Number 00000442592CN2; System ID Number 480342APEX, UDI (01)00840682146616(11)220900(21)REV2A2200072CN, Mfg. Lot/Serial Number REV2A2200072CN; 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 11320, UDI To be provided, Mfg. Lot/Serial Number REVVX2000033CN; System ID Number 949250APEX, UDI (01)00195278460271(11)230500(21)REV2X2300008CN, Mfg. Lot/Serial Number REV2X2300008CN; System ID Number 858657APEX, UDI (01)00840682118552(11)160900(21)REVVX1600034CN, Mfg. Lot/Serial Number REVVX1600034CN; System ID Number 858824REV, UDI (01)00195278460271(11)241100(21)REV2X2400147CN, Mfg. Lot/Serial Number REV2X2400147CN; System ID Number 858824APEX, UDI Not Applicable, Mfg. Lot/Serial Number 00000443327CN2; System ID Number 310423CT, UDI (01)00840682118552(11)211200(21)REVVX2100047CN, Mfg. Lot/Serial Number REVVX2100047CN; System ID Number 707257APEX1, UDI (01)0019

UPC codes

00195278460271, 00840682123471, 00840682146616, 00840682118552

Source

Official record: FDA (Device enforcement) ↗

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