GE Medical Systems, LLC: GE Healthcare Revolution Apex, 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: 56 units Lot/code info: System ID Number: 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number: 650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN; System ID Number: 630266CTRV, UDI (01)00195278460271(11)240800(21)REV2X2400093CN, Mfg. Lot/Serial Number REV2X2400093CN; System ID Number: 773702REVCT6ED, UDI (01)00195278460271(11)231000(21)REV2X2300071CN, Mfg. Lot/Serial Number REV2X2300071CN; System ID Number: 312996CTRV2, UDI (01)00195278460271(11)241000(21)REV2X2400126CN, Mfg. Lot/Serial Number REV2X2400126CN; System ID Number: 1000000018, UDI To be provided, Mfg. Lot/Serial Number REV2X2300074CN; System ID Number: 617726Y6REV2, UDI (01)00840682118552(11)170900(21)REVVX1700090CN, Mfg. Lot/Serial Number REVVX1700090CN; System ID Number: 617726Y6REV1, UDI (01)00840682118552(11)160700(21)REVVX1600018CN, Mfg. Lot/Serial Number REVVX1600018CN; System ID Number: 336890APEX, UDI (01)00195278460271(11)240900(21)REV2X2400116CN, Mfg. Lot/Serial Number REV2X2400116CN; System ID Number: 704801APEX, UDI (01)00195278460271(11)241000(21)REV2X2400139CN, Mfg. Lot/Serial Number REV2X2400139CN; System ID Number: 336832APEX, UDI (01)00195278460271(11)241000(21)REV2X2400129CN, Mfg. Lot/Serial Number REV2X2400129CN; System ID Number: 980993CT1, UDI (01)00840682146616(11)210700(21)REV2A2100029CN, Mfg. Lot/Serial Number REV2A2100029CN; System ID Number: 910715REV1, UDI (01)00195278460271(11)241200(21)REV2X2400155CN, Mfg. Lot/Serial Numbe

UPC codes

00195278460271, 00840682118552, 00840682146616, 00195278469700, 00840682123471, 082421140968, 082421140960, 00195278633149, 082421140959

Source

Official record: FDA (Device enforcement) ↗

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