GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
FDA recall Z-1298-2025 — GE Medical Systems, LLC is recalling GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
openFDA drug & device enforcement (recall) reports
FDA recall Z-1298-2025: GE Medical Systems, LLC is recalling GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
The FDA logged enforcement record Z-1298-2025: GE Medical Systems, LLC is voluntarily recalling GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed — reason: 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-18. Affected lots/codes: 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(11)240800(21)REV2X2400095CN, Mfg. Lot/Serial Number REV2X2400095CN; System ID Number 302744APEX, UDI (01)00195278460271(11)240600(21)REV2X2400078CN, Mfg. Lot/Serial Number REV2X2400078CN; System ID Number 561737APEX1, UDI (01)00195278460271(11)240900(21)REV2X2400114CN, Mfg. Lot/Serial Number REV2X2400114CN; System ID Number 561737APEX2, UDI (01)00195278460271(11)240900(21)REV2X2400112CN, Mfg. Lot/Serial Number REV2X2400112CN; System ID Number 786243APEX1, UDI (01)00195278460271(11)230900(21)REV2X2300059CN, Mfg. Lot/Serial Number REV2X2300059CN; System ID Number 305323APEX, UDI (01)00195278460271(11)240900(21)REV2X2400123CN, Mfg. Lot/Serial Number REV2X2400123CN; System ID Number 904UFNAPEX, UDI (01)00195278460271(11)230300(21)REV2X2300001CN, Mfg. Lot/Serial Number REV2X2300001CN; System ID Number 863680APEX, UDI (01)00195278460271(11)230900(21)REV2X2300057CN, Mfg. Lot/Serial Number REV2X2300057CN; System ID Number 786596APEX, UDI (01)00195278460271(11)230900(21)REV2X2300068CN, Mfg. Lot/Serial Number REV2X2300068CN; System ID Number 813972APEX, UDI (01)00195278460271(11)230800(21)REV2X2300041CN, Mfg. Lot/Serial Number REV2X2300041CN; System ID Number 813972APEX2, UDI (01)00195278460271(11)240700(21)REV2X2400088CN, Mfg. Lot/Serial Number REV2X2400088CN; System ID Number 813972APEX3, UDI (01)00195278460271(11)241000(21)REV2X2400135CN, Mfg. Lot/Serial Number REV2X2400135CN; System ID Number 770219APEX1, UDI (01)00195278460271(11)240800(21)REV2X2400100CN, Mfg. Lot/Serial Number REV2X2400100CN; 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 708245APEX1, UDI (01)00195278460271(11)230900(21)REV2X2300064CN, Mfg. Lot/Serial Number REV2X2300064CN; System ID Number 309454APEX1, UDI (01)00195278460271(11)230900(21)REV2X2300058CN, Mfg. Lot/Serial Number REV2X2300058CN; System ID Number 1000000018, UDI To be provided, Mfg. Lot/Serial Number REV2X2300074CN; System ID Number 1000005353, UDI To be provided, Mfg. Lot/Serial Number REV2X2400148CN; System ID Number 815968CTRV, UDI (01)00195278460271(11)240600(21)REV2X2400075CN, Mfg. Lot/Serial Number REV2X2400075CN; System ID Number 317621APEX1, UDI (01)00195278460271(11)240800(21)REV2X2400098CN, Mfg. Lot/Serial Number REV2X2400098CN; System ID Number 913588APEX1, UDI (01)00195278460271(11)230700(21)REV2X2300042CN, Mfg. Lot/Serial Number REV2X2300042CN; System ID Number 913588APEX2, UDI (01)00195278460271(11)231200(21)REV2X2300091CN, Mfg. Lot/Serial Number REV2X2300091CN; System ID Number 270444APEXCT, UDI To be provided, Mfg. Lot/Serial Number REV2X2300083CN; System ID Number 606451APEX1, UDI (01)00195278460271(11)240200(21)REV2X2400013CN, Mfg. Lot/Serial Number REV2X2400013CN; System ID Number 516252APEX, UDI (01)00195278460271(11)230600(21)REV2X2300020CN, Mfg. Lot/Serial Number REV2X2300020CN; System ID Number 508971REV, UDI (01)00195278460271(11)241000(21)REV2X2400124CN, Mfg. Lot/Serial Number REV2X2400124CN; System ID Number 412607CT1, UDI (01)00195278460271(11)241000(21)REV2X2400127CN, Mfg. Lot/Serial Number REV2X2400127CN; System ID Number 248898APEX1, UDI To be provided, Mfg. Lot/Serial Number REV2X2300096CN; System ID Number 816271SJCT12, UDI (01)00195278460271(11)230500(21)REV2X2300013CN, Mfg. Lot/Serial Number REV2X2300013CN; System ID Number 314251APEX, UDI (01)00195278460271(11)230600(21)REV2X2300022CN, Mfg. Lot/Serial Number REV2X2300022CN; 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 336884APEX, UDI (01)00195278460271(11)240500(21)REV2X2400064CN, Mfg. Lot/Serial Number REV2X2400064CN; System ID Number 910715REV1, UDI (01)00195278460271(11)241200(21)REV2X2400155CN, Mfg. Lot/Serial Number REV2X2400155CN; System ID Number 402559REV6, UDI (01)00195278460271(11)240400(21)REV2X2400044CN, Mfg. Lot/Serial Number REV2X2400044CN; System ID Number 603650APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400068CN, Mfg. Lot/Serial Number REV2X2400068CN; System ID Number 856886CTAPEX, UDI (01)00195278460271(11)240600(21)REV2X2400071CN, Mfg. Lot/Serial Number REV2X2400071CN; System ID Number 856355CTREV, UDI (01)00195278460271(11)230600(21)REV2X2300018CN, Mfg. Lot/Serial Number REV2X2300018CN; System ID Number 973971REV161, UDI (01)00195278460271(11)241200(21)REV2X2400158CN, Mfg. Lot/Serial Number REV2X2400158CN; System ID Number 973940APEX1, UDI (01)00195278460271(11)230400(21)REV2X2300006CN, Mfg. Lot/Serial Number REV2X2300006CN; System ID Number 973831APEX1, UDI (01)00195278460271(11)240300(21)REV2X2400023CN, Mfg. Lot/Serial Number REV2X2400023CN; System ID Number 973971APEX3, UDI To be provided, Mfg. Lot/Serial Number REV2A2200101CN; System ID Number 505722APEX1, UDI (01)00195278460271(11)230900(21)REV2X2300056CN, Mfg. Lot/Serial Number REV2X2300056CN; System ID Number 575556REV1, UDI (01)00195278460271(11)241100(21)REV2X2400149CN, Mfg. Lot/Serial Number REV2X2400149CN; System ID Number 702961PCT, UDI (01)00195278460271(11)230900(21)REV2X2300063CN, Mfg. Lot/Serial Number REV2X2300063CN; System ID Number 702962RRCT, UDI (01)00195278460271(11)240700(21)REV2X2400086CN, Mfg. Lot/Serial Number REV2X2400086CN; System ID Number 718932APEX1, UDI (01)00195278460271(11)230600(21)REV2X2300028CN, Mfg. Lot/Serial Number REV2X2300028CN; System ID Number 914787APEX, UDI (01)00195278460271(11)231000(21)REV2X2300081CN, Mfg. Lot/Serial Number REV2X2300081CN; System ID Number 718963EDCT, UDI (01)00195278460271(11)240600(21)REV2X2400070CN, Mfg. Lot/Serial Number REV2X2400070CN; System ID Number 914737APEX, UDI (01)00195278460271(11)240900(21)REV2X2400110CN, Mfg. Lot/Serial Number REV2X2400110CN; System ID Number 631670APEX1, UDI (01)00195278460271(11)240800(21)REV2X2400107CN, Mfg. Lot/Serial Number REV2X2400107CN; System ID Number 516MHCTED1, UDI (01)00195278460271(11)231200(21)REV2X2300090CN, Mfg. Lot/Serial Number REV2X2300090CN; System ID Number HARLEMAPEXCT, UDI To be provided, Mfg. Lot/Serial Number REV2X2300095CN; System ID Number 718226VZAPEX, UDI (01)00195278460271(11)230500(21)REV2X2300009CN, Mfg. Lot/Serial Number REV2X2300009CN; System ID Number 315473APEX1, UDI (01)00195278460271(11)241100(21)REV2X2400152CN, Mfg. Lot/Serial Number REV2X2400152CN; System ID Number 914681APEXCT1, UDI To be provided, Mfg. Lot/Serial Number REV2X2300097CN; System ID Number 330729CTAPX2, UDI (01)00195278460271(11)230300(21)REV2X2300003CN, Mfg. Lot/Serial Number REV2X2300003CN; System ID Number 614RMHAPEX1, UDI (01)00195278460271(11)240300(21)REV2X2400026CN, Mfg. Lot/Serial Number REV2X2400026CN; System ID Number 614RMHAPEX2, UDI (01)00195278460271(11)240300(21)REV2X2400028CN, Mfg. Lot/Serial Number REV2X2400028CN; System ID Number 330841APEX1, UDI (01)00195278460271(11)240900(21)REV2X2400115CN, Mfg. Lot/Serial Number REV2X2400115CN; System ID Number 330480APEX1, UDI (01)00195278460271(11)240900(21)REV2X2400113CN, Mfg. Lot/Serial Number REV2X2400113CN; System ID Number 580559APEX160, UDI (01)00195278460271(11)230300(21)REV2X2300002CN, Mfg. Lot/Serial Number REV2X2300002CN; System ID Number 484526APEX, UDI (01)00195278460271(11)240300(21)REV2X2400027CN, Mfg. Lot/Serial Number REV2X2400027CN; System ID Number 717960CTAPEX, UDI To be provided, Mfg. Lot/Serial Number REV2X2500007CN; System ID Number 717267CTREV, UDI (01)00195278460271(11)240300(21)REV2X2400030CN, Mfg. Lot/Serial Number REV2X2400030CN; System ID Number 724357APEX, UDI (01)00195278460271(11)230800(21)REV2X2300046CN, Mfg. Lot/Serial Number REV2X2300046CN; System ID Number 864512APEX1, UDI (01)00195278460271(11)240500(21)REV2X2400059CN, Mfg. Lot/Serial Number REV2X2400059CN; System ID Number 864725APEX2, UDI (01)00195278460271(11)230700(21)REV2X2300040CN, Mfg. Lot/Serial Number REV2X2300040CN; System ID Number 864560APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300084CN, Mfg. Lot/Serial Number REV2X2300084CN; System ID Number 731541APX1, UDI (01)00195278460271(11)230600(21)REV2X2300024CN, Mfg. Lot/Serial Number REV2X2300024CN; System ID Number 512544APEX1, UDI (01)00195278460271(11)240800(21)REV2X2400106CN, Mfg. Lot/Serial Number REV2X2400106CN; System ID Number 512447APEX, UDI (01)00195278460271(11)240700(21)REV2X2400080CN, Mfg. Lot/Serial Number REV2X2400080CN; System ID Number 832325REV, UDI (01)00195278460271(11)241000(21)REV2X2400134CN, Mfg. Lot/Serial Number REV2X2400134CN; System ID Number 281477APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400069CN, Mfg. Lot/Serial Number REV2X2400069CN; System ID Number 281477APEX3, UDI (01)00195278460271(11)240600(21)REV2X2400063CN, Mfg. Lot/Serial Number REV2X2400063CN; System ID Number 713R3ACT49, UDI (01)00195278460271(11)240900(21)REV2X2400117CN, Mfg. Lot/Serial Number REV2X2400117CN; System ID Number 713442REVEVO3, UDI (01)00195278460271(11)241100(21)REV2X2400150CN, Mfg. Lot/Serial Number REV2X2400150CN; System ID Number 713790APEX2, UDI To be provided, Mfg. Lot/Serial Number REV2X2300086CN; System ID Number 713790APEX, UDI (01)00195278460271(11)230900(21)REV2X2300060CN, Mfg. Lot/Serial Number REV2X2300060CN; System ID Number 713R3ACT48, UDI (01)00195278460271(11)241000(21)REV2X2400128CN, Mfg. Lot/Serial Number REV2X2400128CN; System ID Number 414559REV1, UDI (01)00195278460271(11)241100(21)REV2X2400141CN, Mfg. Lot/Serial Number REV2X2400141CN; System ID Number 409772CT, UDI (01)00195278460271(11)240800(21)REV2X2400097CN, Mfg. Lot/Serial Number REV2X2400097CN; System ID Number 210757APEX, UDI (01)00195278460271(11)230800(21)REV2X2300049CN, Mfg. Lot/Serial Number REV2X2300049CN; System ID Number 806775APEX, UDI (01)00195278460271(11)231000(21)REV2X2300075CN, Mfg. Lot/Serial Number REV2X2300075CN; System ID Number 806775APEX1, UDI (01)00195278460271(11)230900(21)REV2X2300061CN, Mfg. Lot/Serial Number REV2X2300061CN; System ID Number 713790APEX1, UDI (01)00195278460271(11)230900(21)REV2X2300062CN, Mfg. Lot/Serial Number REV2X2300062CN; System ID Number 713442APEX, UDI (01)00195278460271(11)230700(21)REV2X2300036CN, Mfg. Lot/Serial Number REV2X2300036CN; System ID Number 713442REVEVO5, UDI (01)00195278460271(11)241200(21)REV2X2400156CN, Mfg. Lot/Serial Number REV2X2400156CN; System ID Number 385531CT2, UDI (01)00195278460271(11)231000(21)REV2X2300076CN, Mfg. Lot/Serial Number REV2X2300076CN; System ID Number 703504APEX, UDI (01)00195278460271(11)240900(21)REV2X2400111CN, Mfg. Lot/Serial Number REV2X2400111CN; System ID Number 434654CT, UDI (01)00195278460271(11)230600(21)REV2X2300025CN, Mfg. Lot/Serial Number REV2X2300025CN; System ID Number 703391APEX1, UDI (01)00195278460271(11)240900(21)REV2X2400118CN, Mfg. Lot/Serial Number REV2X2400118CN; System ID Number 703776APEX, UDI To be provided, Mfg. Lot/Serial Number REV2X2400167CN; System ID Number 804594APEX1, UDI (01)00195278460271(11)240400(21)REV2X2400041CN, Mfg. Lot/Serial Number REV2X2400041CN; System ID Number 804267APEX1, UDI (01)00195278460271(11)240200(21)REV2X2400009CN, Mfg. Lot/Serial Number REV2X2400009CN; System ID Number 425688REV, UDI (01)00195278460271(11)241000(21)REV2X2400132CN, Mfg. Lot/Serial Number REV2X2400132CN; System ID Number 206223REV1, UDI (01)00195278460271(11)241200(21)REV2X2400161CN, Mfg. Lot/Serial Number REV2X2400161CN; System ID Number 608890APEXELITE, UDI (01)00195278460271(11)240700(21)REV2X2400081CN, Mfg. Lot/Serial Number REV2X2400081CN; System ID Number 262577REVCT, UDI (01)00195278460271(11)240500(21)REV2X2400055CN, Mfg. Lot/Serial Number REV2X2400055CN; System ID Number AUCTX25000302, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number 832CT000234, UDI (01)00195278460271(11)240200(21)AEGGL2400002YC, Mfg. Lot/Serial Number AEGGL2400002YC; System ID Number AUCTX24429383, UDI (01)00195278460271(11)240700(21)AEGGL2400008YC, Mfg. Lot/Serial Number AEGGL2400008YC; System ID Number AUCTX24814311, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number 832CT000230, UDI (01)00195278460271(11)240400(21)AEGGL2400004YC, Mfg. Lot/Serial Number AEGGL2400004YC; System ID Number AUCTX24566130, UDI (01)00195278460271(11)241000(21)CBGMG2400005HM, Mfg. Lot/Serial Number CBGMG2400005HM; System ID Number 833CT000211, UDI (01)00195278460271(11)231000(21)REV2X2300080CN, Mfg. Lot/Serial Number REV2X2300080CN; System ID Number AUCTX24493342, UDI To be provided, Mfg. Lot/Serial Number CBGMG2400001HM; System ID Number AUCTX24493214, UDI To be provided, Mfg. Lot/Serial Number CBGMG2400003HM; System ID Number AUCTX24491472, UDI To be provided, Mfg. Lot/Serial Number CBGMG2400004HM; System ID Number 833CT000155, UDI (01)00195278460271(11)240500(21)REV2X2400053CN, Mfg. Lot/Serial Number REV2X2400053CN; System ID Number AH4001CT06, UDI (01)00195278460271(11)240500(21)REV2X2300054CN, Mfg. Lot/Serial Number REV2X2300054CN; System ID Number AH1923CT01, UDI (01)00195278460271(11)240300(21)REV2X2400024CN, Mfg. Lot/Serial Number REV2X2400024CN; System ID Number 140024CT04, UDI To be provided, Mfg. Lot/Serial Number REV2A2200013CN; System ID Number 220826CT05, UDI (01)00195278460271(11)240100(21)REV2X2400002CN, Mfg. Lot/Serial Number REV2X2400002CN; System ID Number 110094CT02, UDI (01)00195278460271(11)230500(21)REV2X2300011CN, Mfg. Lot/Serial Number REV2X2300011CN; System ID Number 441239APEX1, UDI To be provided, Mfg. Lot/Serial Number REV2X2400166CN; System ID Number REV2X2400004CN, UDI (01)00195278460271(11)240100(21)REV2X2400004CN, Mfg. Lot/Serial Number REV2X2400004CN; System ID Number REV2X2400076CN, UDI (01)00195278460271(11)240600(21)REV2X2400076CN, Mfg. Lot/Serial Number REV2X2400076CN; System ID Number 12906848, UDI (01)00195278460271(11)241100(21)REV2X2400140CN, Mfg. Lot/Serial Number REV2X2400140CN; System ID Number BG4549CT04, UDI (01)00195278460271(11)230600(21)REV2X2300026CN, Mfg. Lot/Serial Number REV2X2300026CN; System ID Number 604557APEXRT1, UDI (01)00195278460271(11)241000(21)REV2X2400133CN, Mfg. Lot/Serial Number REV2X2400133CN; System ID Number 250635APEX, UDI (01)00195278460271(11)240400(21)REV2X2400045CN, Mfg. Lot/Serial Number REV2X2400045CN; System ID Number 5349227CT11, UDI (01)00195278460271(11)240300(21)REV2X2400022CN, Mfg. Lot/Serial Number REV2X2400022CN; System ID Number 867975APEX, UDI (01)00195278460271(11)240500(21)REV2X2400047CN, Mfg. Lot/Serial Number REV2X2400047CN; System ID Number 905522REVCT1, UDI To be provided, Mfg. Lot/Serial Number REV2X2400056CN; System ID Number 905522REVCT2, UDI (01)00195278460271(11)241200(21)REV2X2400157CN, Mfg. Lot/Serial Number REV2X2400157CN; System ID Number E416249APEXCTE, UDI (01)00195278460271(11)231100(21)REV2X2300087CN, Mfg. Lot/Serial Number REV2X2300087CN; System ID Number E416249APEXCT2, UDI (01)00195278460271(11)240500(21)REV2X2400052CN, Mfg. Lot/Serial Number REV2X2400052CN; System ID Number E416249APEXCT1, UDI (01)00195278460271(11)240700(21)REV2X2400089CN, Mfg. Lot/Serial Number REV2X2400089CN; System ID Number 705522REVCT2, UDI (01)00195278460271(11)240300(21)REV2X2400029CN, Mfg. Lot/Serial Number REV2X2400029CN; System ID Number APEX160CMEXZ01, UDI To be provided, Mfg. Lot/Serial Number CBFCG2300002HM; System ID Number 12044778, UDI (01)00195278460271(11)240800(21)REV2X2400073CN, Mfg. Lot/Serial Number REV2X2400073CN; System ID Number DK1039CT02, UDI (01)00195278460271(11)230600(21)REV2X2300027CN, Mfg. Lot/Serial Number REV2X2300027CN; System ID Number DK1106CT02, UDI (01)00195278460271(11)230900(21)REV2X2300055CN, Mfg. Lot/Serial Number REV2X2300055CN; System ID Number DK1066CT01, UDI (01)00195278460271(11)221100(21)REV2X2200001CN, Mfg. Lot/Serial Number REV2X2200001CN; System ID Number DK1009CT01, UDI (01)00195278460271(11)221200(21)REV2X2200002CN, Mfg. Lot/Serial Number REV2X2200002CN; System ID Number CT52261701, UDI To be provided, Mfg. Lot/Serial Number REV2X2300050CN; System ID Number FI1003CT14, UDI To be provided, Mfg. Lot/Serial Number REV2X2400164CN; System ID Number 09974427, UDI (01)00195278460271(11)240800(21)REV2X2400094CN, Mfg. Lot/Serial Number REV2X2400094CN; System ID Number 12107537, UDI (01)00195278460271(11)240700(21)REV2X2400090CN, Mfg. Lot/Serial Number REV2X2400090CN; System ID Number 08089969, UDI (01)00195278460271(11)230400(21)REV2X2300004CN, Mfg. Lot/Serial Number REV2X2300004CN; System ID Number 11525316, UDI To be provided, Mfg. Lot/Serial Number REV2X2400082CN; System ID Number 11379817, UDI (01)00195278460271(11)240700(21)REV2X2400084CN, Mfg. Lot/Serial Number REV2X2400084CN; System ID Number 259056CT01, UDI (01)00195278460271(11)230800(21)REV2X2300051CN, Mfg. Lot/Serial Number REV2X2300051CN; System ID Number HU1766CT01, UDI To be provided, Mfg. Lot/Serial Number REV2X2400096CN; System ID Number 12743158, UDI To be provided, Mfg. Lot/Serial Number REV2X2400058CN; System ID Number 083021862540324, UDI (01)00195278460271(11)240800(21)REV2X2400101CN, Mfg. Lot/Serial Number REV2X2400101CN; System ID Number 7982CT0354, UDI (01)00195278460271(11)240200(21)REV2X2400011CN, Mfg. Lot/Serial Number REV2X2400011CN; System ID Number 7982CT0360, UDI (01)00195278460271(11)240100(21)REV2X2400005CN, Mfg. Lot/Serial Number REV2X2400005CN; System ID Number 11960464, UDI (01)00195278460271(11)240800(21)REV2X2400099CN, Mfg. Lot/Serial Number REV2X2400099CN; System ID Number 08876643, UDI (01)00195278460271(11)230700(21)REV2X2300037CN, Mfg. Lot/Serial Number REV2X2300037CN; System ID Number 10025899, UDI (01)00195278460271(11)240200(21)REV2X2400016CN, Mfg. Lot/Serial Number REV2X2400016CN; System ID Number 08867431, UDI (01)00195278460271(11)231000(21)REV2X2300078CN, Mfg. Lot/Serial Number REV2X2300078CN; System ID Number 09897949, UDI (01)00195278460271(11)240700(21)REV2X2400092CN, Mfg. Lot/Serial Number REV2X2400092CN; System ID Number 12128152, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number CT00442, UDI (01)00195278460271(11)230600(21)REV2X2300017CN, Mfg. Lot/Serial Number REV2X2300017CN; System ID Number CT00494, UDI (01)00195278460271(11)231000(21)REV2X2300070CN, Mfg. Lot/Serial Number REV2X2300070CN; System ID Number CT00495, UDI (01)00195278460271(11)231000(21)AEGGL2300001YC, Mfg. Lot/Serial Number AEGGL2300001YC; System ID Number CT00639, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number CT00638, UDI (01)00195278460271(11)241100(21)CBGMG2400008HM, Mfg. Lot/Serial Number CBGMG2400008HM; System ID Number CT00468, UDI (01)00195278460271(11)240400(21)AEGGL2400005YC, Mfg. Lot/Serial Number AEGGL2400005YC; System ID Number CT00381, UDI (01)00195278460271(11)221100(21)REV2X2200003CN, Mfg. Lot/Serial Number REV2X2200003CN; System ID Number CT00611, UDI (01)00195278460271(11)240700(21)AEGGL2400009YC, Mfg. Lot/Serial Number AEGGL2400009YC; System ID Number CT00637, UDI (01)00195278460271(11)241100(21)CBGMG2400013HM, Mfg. Lot/Serial Number CBGMG2400013HM; System ID Number CT00488, UDI (01)00195278460271(11)231100(21)AEGGL2300002YC, Mfg. Lot/Serial Number AEGGL2300002YC; System ID Number CT00496, UDI To be provided, Mfg. Lot/Serial Number AEGGL2300006YC; System ID Number CT00457, UDI (01)00195278460271(11)230900(21)REV2X2300052CN, Mfg. Lot/Serial Number REV2X2300052CN; System ID Number CT00515, UDI To be provided, Mfg. Lot/Serial Number AEGGL2300004YC; System ID Number CT00516, UDI (01)00195278460271(11)231200(21)AEGGL2300007YC, Mfg. Lot/Serial Number AEGGL2300007YC; System ID Number CT00552, UDI (01)00195278460271(11)240200(21)AEGGL2400003YC, Mfg. Lot/Serial Number AEGGL2400003YC; System ID Number CT00460, UDI (01)00195278460271(11)231100(21)AEGGL2300003YC, Mfg. Lot/Serial Number AEGGL2300003YC; System ID Number CT00486, UDI (01)00195278460271(11)231000(21)REV2X2300079CN, Mfg. Lot/Serial Number REV2X2300079CN; System ID Number KRCT54972221, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number KRCT54893311, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number KRCT54358591, UDI To be provided, Mfg. Lot/Serial Number AEGGL2400010YC; System ID Number KRCT54358601, UDI To be provided, Mfg. Lot/Serial Number AEGGL2400013YC; System ID Number 0850211084, UDI To be provided, Mfg. Lot/Serial Number REV2X2300016CN; System ID Number KRCT54933611, UDI To be provided, Mfg. Lot/Serial Number AEGGL2400014YC; System ID Number 0850211108, UDI (01)00195278460271(11)231200(21)REV2X2300092CN, Mfg. Lot/Serial Number REV2X2300092CN; System ID Number 0850211121, UDI (01)00195278460271(11)240600(21)REV2X2400066CN, Mfg. Lot/Serial Number REV2X2400066CN; System ID Number 0850211094, UDI (01)00195278460271(11)230800(21)REV2X2300048CN, Mfg. Lot/Serial Number REV2X2300048CN; System ID Number 110807CT06, UDI (01)00195278460271(11)241200(21)REV2X2400162CN, Mfg. Lot/Serial Number REV2X2400162CN; System ID Number 0828210145, UDI (01)00195278460271(11)231000(21)REV2X2300073CN, Mfg. Lot/Serial Number REV2X2300073CN; System ID Number LWD0320, UDI (01)00195278460271(11)230700(21)REV2X2300032CN, Mfg. Lot/Serial Number REV2X2300032CN; System ID Number LWD0324, UDI (01)00195278460271(11)231000(21)REV2X2300069CN, Mfg. Lot/Serial Number REV2X2300069CN; System ID Number 859CT000226, UDI (01)00195278460271(11)240400(21)REV2X2400042CN, Mfg. Lot/Serial Number REV2X2400042CN; System ID Number 859CT000190, UDI (01)00195278460271(11)230900(21)REV2X2300053CN, Mfg. Lot/Serial Number REV2X2300053CN; System ID Number NO1043CT05, UDI (01)00195278460271(11)240400(21)REV2X2300047CN, Mfg. Lot/Serial Number REV2X2300047CN; System ID Number NO1043CT04, UDI (01)00195278460271(11)240500(21)REV2X2400048CN, Mfg. Lot/Serial Number REV2X2400048CN; System ID Number 1557CT0318, UDI (01)00195278460271(11)240500(21)REV2X2400057CN, Mfg. Lot/Serial Number REV2X2400057CN; System ID Number P00652CT01, UDI (01)00195278460271(11)240200(21)REV2X2400017CN, Mfg. Lot/Serial Number REV2X2400017CN; System ID Number 600042CT07, UDI (01)00195278460271(11)240500(21)REV2X2400049CN, Mfg. Lot/Serial Number REV2X2400049CN; System ID Number PPR590118, UDI (01)00195278460271(11)240100(21)REV2X2300099CN, Mfg. Lot/Serial Number REV2X2300099CN; System ID Number SA2980CT01, UDI To be provided, Mfg. Lot/Serial Number REV2X23000029CN; System ID Number SA2973CT01, UDI To be provided, Mfg. Lot/Serial Number REV2X23000030CN; System ID Number CT53972381, UDI To be provided, Mfg. Lot/Serial Number REV2X2400121CN; System ID Number SGCT54294581, UDI (01)00195278460271(11)240600(21)AEGGL2400007YC, Mfg. Lot/Serial Number AEGGL2400007YC; System ID Number 6073CT0103, UDI (01)00195278460271(11)240200(21)REV2X2400010CN, Mfg. Lot/Serial Number REV2X2400010CN; System ID Number SGCTX24467795, UDI (01)00195278460271(11)240700(21)REV2X2400087CN, Mfg. Lot/Serial Number REV2X2400087CN; System ID Number SGCTX24467793, UDI To be provided, Mfg. Lot/Serial Number REV2X2400102CN; System ID Number 12622329, UDI To be provided, Mfg. Lot/Serial Number REV2X2400165CN; System ID Number P002CT03, UDI (01)00195278460271(11)230800(21)REV2X2300045CN, Mfg. Lot/Serial Number REV2X2300045CN; System ID Number L007CT02, UDI (01)00195278460271(11)231200(21)REV2X2300093CN, Mfg. Lot/Serial Number REV2X2300093CN; System ID Number O009CT06, UDI (01)00195278460271(11)230500(21)REV2X2300010CN, Mfg. Lot/Serial Number REV2X2300010CN; System ID Number M007CT03, UDI (01)00195278460271(11)230800(21)REV2X2300043CN, Mfg. Lot/Serial Number REV2X2300043CN; System ID Number L001CT01, UDI (01)00195278460271(11)240100(21)REV2X2300098CN, Mfg. Lot/Serial Number REV2X2300098CN; System ID Number M001CT04, UDI (01)00195278460271(11)230700(21)REV2X2300034CN, Mfg. Lot/Serial Number REV2X2300034CN; System ID Number M001CT02, UDI To be provided, Mfg. Lot/Serial Number REV2X2400003CN; System ID Number M001CT06, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number M004CT02, UDI (01)00195278460271(11)230400(21)REV2X2300005CN, Mfg. Lot/Serial Number REV2X2300005CN; System ID Number R002CT12, UDI (01)00195278460271(11)230500(21)REV2X2300012CN, Mfg. Lot/Serial Number REV2X2300012CN; System ID Number A201CT07, UDI (01)00195278460271(11)240200(21)REV2X2400014CN, Mfg. Lot/Serial Number REV2X2400014CN; System ID Number A201CT05, UDI To be provided, Mfg. Lot/Serial Number REV2X2400130CN; System ID Number 222769CT01, UDI (01)00195278460271(11)231100(21)REV2X2300085CN, Mfg. Lot/Serial Number REV2X2300085CN; System ID Number 529150CT04, UDI (01)00195278460271(11)230600(21)REV2X2300019CN, Mfg. Lot/Serial Number REV2X2300019CN; System ID Number 529150CT02, UDI (01)00195278460271(11)230600(21)REV2X2300023CN, Mfg. Lot/Serial Number REV2X2300023CN; System ID Number 850030CT02, UDI (01)00195278460271(11)230800(21)REV2X2300044CN, Mfg. Lot/Serial Number REV2X2300044CN; System ID Number THCTX24524601, UDI (01)00195278460271(11)241000(21)REV2X2400131CN, Mfg. Lot/Serial Number REV2X2400131CN; System ID Number THCTX24513791, UDI (01)00195278460271(11)240900(21)REV2X2400120CN, Mfg. Lot/Serial Number REV2X2400120CN; System ID Number THCTX24476143, UDI (01)00195278460271(11)241000(21)REV2X2400125CN, Mfg. Lot/Serial Number REV2X2400125CN; System ID Number 12338981, UDI To be provided, Mfg. Lot/Serial Number REV2X2400159CN; System ID Number 10127416, UDI (01)00195278460271(11)240300(21)REV2X2400031CN, Mfg. Lot/Serial Number REV2X2400031CN; System ID Number 09850616, UDI (01)00195278460271(11)240300(21)REV2X2400025CN, Mfg. Lot/Serial Number REV2X2400025CN; System ID Number 09993031, UDI To be provided, Mfg. Lot/Serial Number REV2X2400012CN; System ID Number 10396521, UDI (01)00195278460271(11)240400(21)REV2X2400040CN, Mfg. Lot/Serial Number REV2X2400040CN; System ID Number 09904040, UDI (01)00195278460271(11)240100(21)REV2X2400007CN, Mfg. Lot/Serial Number REV2X2400007CN; System ID Number 10493318, UDI (01)00195278460271(11)240400(21)REV2X2400037CN, Mfg. Lot/Serial Number REV2X2400037CN; System ID Number 09526282, UDI (01)00195278460271(11)241100(21)REV2X2400145CN, Mfg. Lot/Serial Number REV2X2400145CN; System ID Number 10127401, UDI (01)00195278460271(11)240200(21)REV2X2400018CN, Mfg. Lot/Serial Number REV2X2400018CN; System ID Number 10131630, UDI To be provided, Mfg. Lot/Serial Number REV2X2400020CN; System ID Number 10231464, UDI To be provided, Mfg. Lot/Serial Number REV2X2500002CN; System ID Number 9830CT0444, UDI (01)00195278460271(11)240700(21)REV2X2400083CN, Mfg. Lot/Serial Number REV2X2400083CN; System ID Number VNCTX24476164, UDI (01)00195278460271(11)240800(21)REV2X2400103CN, Mfg. Lot/Serial Number REV2X2400103CN; System ID Number VNCT5320632A, UDI (01)00195278460271(11)240400(21)REV2X2400036CN, Mfg. Lot/Serial Number REV2X2400036CN; System ID Number VNCTX24515754, UDI (01)00195278460271(11)240900(21)REV2X2400122CN, Mfg. Lot/Serial Number REV2X2400122CN. A RECORDED FDA enforcement action (occurred=true).
openFDA drug & device enforcement (recall) reports — U.S. FDA
A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.
FDA classified recall Z-1298-2025 as Class II
The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
U.S. FDA recall classification (openFDA enforcement)
occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.
A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
a recorded enforcement action, not proof of harm or causation; not medical advice
occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.
Ongoing — the recall is still being carried out.
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.