Class IIOngoingZ-1298-2025
GE Medical Systems, LLC recalls GE Healthcare Revolution Apex Elite
GE Medical Systems, LLCWaukesha, WI, United StatesReported Mar 19, 2025 · 1 year ago
Legal News Analyst ·
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
Lot / code information
- UDI
- (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/
- Serial #
- REV2X2300082CN; System ID Number 256265STCT
- UDI
- (01)00195278460271(11)230600(21)REV2X2300021CN, Mfg. Lot/
- Serial #
- REV2X2300021CN; System ID Number 480342APEX1
- UDI
- (01)00195278460271(11)240600(21)REV2X2400065CN, Mfg. Lot/
- Serial #
- REV2X2400065CN; System ID Number 480342APEX3
- UDI
- (01)00195278460271(11)240600(21)REV2X2400067CN, Mfg. Lot/
- Serial #
- REV2X2400067CN; System ID Number 949250APEX
- UDI
- (01)00195278460271(11)230500(21)REV2X2300008CN, Mfg. Lot/
- Serial #
- REV2X2300008CN; System ID Number 858824REV
- UDI
- (01)00195278460271(11)241100(21)REV2X2400147CN, Mfg. Lot/
- Serial #
- REV2X2400147CN; System ID Number 707257APEX1
- UDI
- (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/
- Serial #
- REV2X2300077CN; System ID Number 714456APEX
- UDI
- (01)00195278460271(11)231200(21)REV2X2300094CN, Mfg. Lot/
- Serial #
- REV2X2300094CN; System ID Number 719227APEX1
- UDI
- (01)00195278460271(11)240200(21)REV2X2400019CN, Mfg. Lot/
- Serial #
- REV2X2400019CN; System ID Number 970945CT
- UDI
- (01)00195278460271(11)240400(21)REV2X2400046CN, Mfg. Lot/
- Serial #
- REV2X2400046CN; System ID Number 203576EDAPEX
- UDI
- (01)00195278460271(11)240300(21)REV2X2400021CN, Mfg. Lot/
- Serial #
- REV2X2400021CN; System ID Number 860224EDAPEX
- UDI
- (01)00195278460271(11)240500(21)REV2X2400050CN, Mfg. Lot/
- Serial #
- REV2X2400050CN; System ID Number 203276APEX1
- UDI
- (01)00195278460271(11)240800(21)REV2X2400095CN, Mfg. Lot/
- Serial #
- REV2X2400095CN; System ID Number 302744APEX
- UDI
- (01)00195278460271(11)240600(21)REV2X2400078CN, Mfg. Lot/
- Serial #
- REV2X2400078CN; System ID Number 561737APEX1
- UDI
- (01)00195278460271(11)240900(21)REV2X2400114CN, Mfg. Lot/
- Serial #
- REV2X2400114CN; System ID Number 561737APEX2
- UDI
- (01)00195278460271(11)240900(21)REV2X2400112CN, Mfg. Lot/
- Serial #
- REV2X2400112CN; System ID Number 786243APEX1
- UDI
- (01)00195278460271(11)230900(21)REV2X2300059CN, Mfg. Lot/
- Serial #
- REV2X2300059CN; System ID Number 305323APEX
- UDI
- (01)00195278460271(11)240900(21)REV2X2400123CN, Mfg. Lot/
- Serial #
- REV2X2400123CN; System ID Number 904UFNAPEX
- UDI
- (01)00195278460271(11)230300(21)REV2X2300001CN, Mfg. Lot/
- Serial #
- REV2X2300001CN; System ID Number 863680APEX
- UDI
- (01)00195278460271(11)230900(21)REV2X2300057CN, Mfg. Lot/
- Serial #
- REV2X2300057CN; System ID Number 786596APEX
- UDI
- (01)00195278460271(11)230900(21)REV2X2300068CN, Mfg. Lot/
- Serial #
- REV2X2300068CN; System ID Number 813972APEX
- UDI
- (01)00195278460271(11)230800(21)REV2X2300041CN, Mfg. Lot/
- Serial #
- REV2X2300041CN; System ID Number 813972APEX2
- UDI
- (01)00195278460271(11)240700(21)REV2X2400088CN, Mfg. Lot/
- Serial #
- REV2X2400088CN; System ID Number 813972APEX3
- UDI
- (01)00195278460271(11)241000(21)REV2X2400135CN, Mfg. Lot/
- Serial #
- REV2X2400135CN; System ID Number 770219APEX1
- UDI
- (01)00195278460271(11)240800(21)REV2X2400100CN, Mfg. Lot/
- Serial #
- REV2X2400100CN; System ID Number 630266CTRV
- UDI
- (01)00195278460271(11)240800(21)REV2X2400093CN, Mfg. Lot/
- Serial #
- REV2X2400093CN; System ID Number 773702REVCT6ED
- UDI
- (01)00195278460271(11)231000(21)REV2X2300071CN, Mfg. Lot/
- Serial #
- REV2X2300071CN; System ID Number 312996CTRV2
- UDI
- (01)00195278460271(11)241000(21)REV2X2400126CN, Mfg. Lot/
- Serial #
- REV2X2400126CN; System ID Number 708245APEX1
- UDI
- (01)00195278460271(11)230900(21)REV2X2300064CN, Mfg. Lot/
- Serial #
- REV2X2300064CN; System ID Number 309454APEX1
- UDI
- (01)00195278460271(11)230900(21)REV2X2300058CN, Mfg. Lot/
- Serial #
- REV2X2300058CN; System ID Number 1000000018
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2300074CN; System ID Number 1000005353
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400148CN; System ID Number 815968CTRV
- UDI
- (01)00195278460271(11)240600(21)REV2X2400075CN, Mfg. Lot/
- Serial #
- REV2X2400075CN; System ID Number 317621APEX1
- UDI
- (01)00195278460271(11)240800(21)REV2X2400098CN, Mfg. Lot/
- Serial #
- REV2X2400098CN; System ID Number 913588APEX1
- UDI
- (01)00195278460271(11)230700(21)REV2X2300042CN, Mfg. Lot/
- Serial #
- REV2X2300042CN; System ID Number 913588APEX2
- UDI
- (01)00195278460271(11)231200(21)REV2X2300091CN, Mfg. Lot/
- Serial #
- REV2X2300091CN; System ID Number 270444APEXCT
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2300083CN; System ID Number 606451APEX1
- UDI
- (01)00195278460271(11)240200(21)REV2X2400013CN, Mfg. Lot/
- Serial #
- REV2X2400013CN; System ID Number 516252APEX
- UDI
- (01)00195278460271(11)230600(21)REV2X2300020CN, Mfg. Lot/
- Serial #
- REV2X2300020CN; System ID Number 508971REV
- UDI
- (01)00195278460271(11)241000(21)REV2X2400124CN, Mfg. Lot/
- Serial #
- REV2X2400124CN; System ID Number 412607CT1
- UDI
- (01)00195278460271(11)241000(21)REV2X2400127CN, Mfg. Lot/
- Serial #
- REV2X2400127CN; System ID Number 248898APEX1
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2300096CN; System ID Number 816271SJCT12
- UDI
- (01)00195278460271(11)230500(21)REV2X2300013CN, Mfg. Lot/
- Serial #
- REV2X2300013CN; System ID Number 314251APEX
- UDI
- (01)00195278460271(11)230600(21)REV2X2300022CN, Mfg. Lot/
- Serial #
- REV2X2300022CN; System ID Number 336890APEX
- UDI
- (01)00195278460271(11)240900(21)REV2X2400116CN, Mfg. Lot/
- Serial #
- REV2X2400116CN; System ID Number 704801APEX
- UDI
- (01)00195278460271(11)241000(21)REV2X2400139CN, Mfg. Lot/
- Serial #
- REV2X2400139CN; System ID Number 336832APEX
- UDI
- (01)00195278460271(11)241000(21)REV2X2400129CN, Mfg. Lot/
- Serial #
- REV2X2400129CN; System ID Number 336884APEX
- UDI
- (01)00195278460271(11)240500(21)REV2X2400064CN, Mfg. Lot/
- Serial #
- REV2X2400064CN; System ID Number 910715REV1
- UDI
- (01)00195278460271(11)241200(21)REV2X2400155CN, Mfg. Lot/
- Serial #
- REV2X2400155CN; System ID Number 402559REV6
- UDI
- (01)00195278460271(11)240400(21)REV2X2400044CN, Mfg. Lot/
- Serial #
- REV2X2400044CN; System ID Number 603650APEX1
- UDI
- (01)00195278460271(11)240600(21)REV2X2400068CN, Mfg. Lot/
- Serial #
- REV2X2400068CN; System ID Number 856886CTAPEX
- UDI
- (01)00195278460271(11)240600(21)REV2X2400071CN, Mfg. Lot/
- Serial #
- REV2X2400071CN; System ID Number 856355CTREV
- UDI
- (01)00195278460271(11)230600(21)REV2X2300018CN, Mfg. Lot/
- Serial #
- REV2X2300018CN; System ID Number 973971REV161
- UDI
- (01)00195278460271(11)241200(21)REV2X2400158CN, Mfg. Lot/
- Serial #
- REV2X2400158CN; System ID Number 973940APEX1
- UDI
- (01)00195278460271(11)230400(21)REV2X2300006CN, Mfg. Lot/
- Serial #
- REV2X2300006CN; System ID Number 973831APEX1
- UDI
- (01)00195278460271(11)240300(21)REV2X2400023CN, Mfg. Lot/
- Serial #
- REV2X2400023CN; System ID Number 973971APEX3
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2A2200101CN; System ID Number 505722APEX1
- UDI
- (01)00195278460271(11)230900(21)REV2X2300056CN, Mfg. Lot/
- Serial #
- REV2X2300056CN; System ID Number 575556REV1
- UDI
- (01)00195278460271(11)241100(21)REV2X2400149CN, Mfg. Lot/
- Serial #
- REV2X2400149CN; System ID Number 702961PCT
- UDI
- (01)00195278460271(11)230900(21)REV2X2300063CN, Mfg. Lot/
- Serial #
- REV2X2300063CN; System ID Number 702962RRCT
- UDI
- (01)00195278460271(11)240700(21)REV2X2400086CN, Mfg. Lot/
- Serial #
- REV2X2400086CN; System ID Number 718932APEX1
- UDI
- (01)00195278460271(11)230600(21)REV2X2300028CN, Mfg. Lot/
- Serial #
- REV2X2300028CN; System ID Number 914787APEX
- UDI
- (01)00195278460271(11)231000(21)REV2X2300081CN, Mfg. Lot/
- Serial #
- REV2X2300081CN; System ID Number 718963EDCT
- UDI
- (01)00195278460271(11)240600(21)REV2X2400070CN, Mfg. Lot/
- Serial #
- REV2X2400070CN; System ID Number 914737APEX
- UDI
- (01)00195278460271(11)240900(21)REV2X2400110CN, Mfg. Lot/
- Serial #
- REV2X2400110CN; System ID Number 631670APEX1
- UDI
- (01)00195278460271(11)240800(21)REV2X2400107CN, Mfg. Lot/
- Serial #
- REV2X2400107CN; System ID Number 516MHCTED1
- UDI
- (01)00195278460271(11)231200(21)REV2X2300090CN, Mfg. Lot/
- Serial #
- REV2X2300090CN; System ID Number HARLEMAPEXCT
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2300095CN; System ID Number 718226VZAPEX
- UDI
- (01)00195278460271(11)230500(21)REV2X2300009CN, Mfg. Lot/
- Serial #
- REV2X2300009CN; System ID Number 315473APEX1
- UDI
- (01)00195278460271(11)241100(21)REV2X2400152CN, Mfg. Lot/
- Serial #
- REV2X2400152CN; System ID Number 914681APEXCT1
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2300097CN; System ID Number 330729CTAPX2
- UDI
- (01)00195278460271(11)230300(21)REV2X2300003CN, Mfg. Lot/
- Serial #
- REV2X2300003CN; System ID Number 614RMHAPEX1
- UDI
- (01)00195278460271(11)240300(21)REV2X2400026CN, Mfg. Lot/
- Serial #
- REV2X2400026CN; System ID Number 614RMHAPEX2
- UDI
- (01)00195278460271(11)240300(21)REV2X2400028CN, Mfg. Lot/
- Serial #
- REV2X2400028CN; System ID Number 330841APEX1
- UDI
- (01)00195278460271(11)240900(21)REV2X2400115CN, Mfg. Lot/
- Serial #
- REV2X2400115CN; System ID Number 330480APEX1
- UDI
- (01)00195278460271(11)240900(21)REV2X2400113CN, Mfg. Lot/
- Serial #
- REV2X2400113CN; System ID Number 580559APEX160
- UDI
- (01)00195278460271(11)230300(21)REV2X2300002CN, Mfg. Lot/
- Serial #
- REV2X2300002CN; System ID Number 484526APEX
- UDI
- (01)00195278460271(11)240300(21)REV2X2400027CN, Mfg. Lot/
- Serial #
- REV2X2400027CN; System ID Number 717960CTAPEX
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2500007CN; System ID Number 717267CTREV
- UDI
- (01)00195278460271(11)240300(21)REV2X2400030CN, Mfg. Lot/
- Serial #
- REV2X2400030CN; System ID Number 724357APEX
- UDI
- (01)00195278460271(11)230800(21)REV2X2300046CN, Mfg. Lot/
- Serial #
- REV2X2300046CN; System ID Number 864512APEX1
- UDI
- (01)00195278460271(11)240500(21)REV2X2400059CN, Mfg. Lot/
- Serial #
- REV2X2400059CN; System ID Number 864725APEX2
- UDI
- (01)00195278460271(11)230700(21)REV2X2300040CN, Mfg. Lot/
- Serial #
- REV2X2300040CN; System ID Number 864560APEX1
- UDI
- (01)00195278460271(11)231100(21)REV2X2300084CN, Mfg. Lot/
- Serial #
- REV2X2300084CN; System ID Number 731541APX1
- UDI
- (01)00195278460271(11)230600(21)REV2X2300024CN, Mfg. Lot/
- Serial #
- REV2X2300024CN; System ID Number 512544APEX1
- UDI
- (01)00195278460271(11)240800(21)REV2X2400106CN, Mfg. Lot/
- Serial #
- REV2X2400106CN; System ID Number 512447APEX
- UDI
- (01)00195278460271(11)240700(21)REV2X2400080CN, Mfg. Lot/
- Serial #
- REV2X2400080CN; System ID Number 832325REV
- UDI
- (01)00195278460271(11)241000(21)REV2X2400134CN, Mfg. Lot/
- Serial #
- REV2X2400134CN; System ID Number 281477APEX1
- UDI
- (01)00195278460271(11)240600(21)REV2X2400069CN, Mfg. Lot/
- Serial #
- REV2X2400069CN; System ID Number 281477APEX3
- UDI
- (01)00195278460271(11)240600(21)REV2X2400063CN, Mfg. Lot/
- Serial #
- REV2X2400063CN; System ID Number 713R3ACT49
- UDI
- (01)00195278460271(11)240900(21)REV2X2400117CN, Mfg. Lot/
- Serial #
- REV2X2400117CN; System ID Number 713442REVEVO3
- UDI
- (01)00195278460271(11)241100(21)REV2X2400150CN, Mfg. Lot/
- Serial #
- REV2X2400150CN; System ID Number 713790APEX2
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2300086CN; System ID Number 713790APEX
- UDI
- (01)00195278460271(11)230900(21)REV2X2300060CN, Mfg. Lot/
- Serial #
- REV2X2300060CN; System ID Number 713R3ACT48
- UDI
- (01)00195278460271(11)241000(21)REV2X2400128CN, Mfg. Lot/
- Serial #
- REV2X2400128CN; System ID Number 414559REV1
- UDI
- (01)00195278460271(11)241100(21)REV2X2400141CN, Mfg. Lot/
- Serial #
- REV2X2400141CN; System ID Number 409772CT
- UDI
- (01)00195278460271(11)240800(21)REV2X2400097CN, Mfg. Lot/
- Serial #
- REV2X2400097CN; System ID Number 210757APEX
- UDI
- (01)00195278460271(11)230800(21)REV2X2300049CN, Mfg. Lot/
- Serial #
- REV2X2300049CN; System ID Number 806775APEX
- UDI
- (01)00195278460271(11)231000(21)REV2X2300075CN, Mfg. Lot/
- Serial #
- REV2X2300075CN; System ID Number 806775APEX1
- UDI
- (01)00195278460271(11)230900(21)REV2X2300061CN, Mfg. Lot/
- Serial #
- REV2X2300061CN; System ID Number 713790APEX1
- UDI
- (01)00195278460271(11)230900(21)REV2X2300062CN, Mfg. Lot/
- Serial #
- REV2X2300062CN; System ID Number 713442APEX
- UDI
- (01)00195278460271(11)230700(21)REV2X2300036CN, Mfg. Lot/
- Serial #
- REV2X2300036CN; System ID Number 713442REVEVO5
- UDI
- (01)00195278460271(11)241200(21)REV2X2400156CN, Mfg. Lot/
- Serial #
- REV2X2400156CN; System ID Number 385531CT2
- UDI
- (01)00195278460271(11)231000(21)REV2X2300076CN, Mfg. Lot/
- Serial #
- REV2X2300076CN; System ID Number 703504APEX
- UDI
- (01)00195278460271(11)240900(21)REV2X2400111CN, Mfg. Lot/
- Serial #
- REV2X2400111CN; System ID Number 434654CT
- UDI
- (01)00195278460271(11)230600(21)REV2X2300025CN, Mfg. Lot/
- Serial #
- REV2X2300025CN; System ID Number 703391APEX1
- UDI
- (01)00195278460271(11)240900(21)REV2X2400118CN, Mfg. Lot/
- Serial #
- REV2X2400118CN; System ID Number 703776APEX
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400167CN; System ID Number 804594APEX1
- UDI
- (01)00195278460271(11)240400(21)REV2X2400041CN, Mfg. Lot/
- Serial #
- REV2X2400041CN; System ID Number 804267APEX1
- UDI
- (01)00195278460271(11)240200(21)REV2X2400009CN, Mfg. Lot/
- Serial #
- REV2X2400009CN; System ID Number 425688REV
- UDI
- (01)00195278460271(11)241000(21)REV2X2400132CN, Mfg. Lot/
- Serial #
- REV2X2400132CN; System ID Number 206223REV1
- UDI
- (01)00195278460271(11)241200(21)REV2X2400161CN, Mfg. Lot/
- Serial #
- REV2X2400161CN; System ID Number 608890APEXELITE
- UDI
- (01)00195278460271(11)240700(21)REV2X2400081CN, Mfg. Lot/
- Serial #
- REV2X2400081CN; System ID Number 262577REVCT
- UDI
- (01)00195278460271(11)240500(21)REV2X2400055CN, Mfg. Lot/
- Serial #
- REV2X2400055CN; System ID Number AUCTX25000302
- UDI
- To be provided, Mfg. Lot/
- Serial #
- t Available; System ID Number 832CT000234
- UDI
- (01)00195278460271(11)240200(21)AEGGL2400002YC, Mfg. Lot/
- Serial #
- AEGGL2400002YC; System ID Number AUCTX24429383
- UDI
- (01)00195278460271(11)240700(21)AEGGL2400008YC, Mfg. Lot/
- Serial #
- AEGGL2400008YC; System ID Number AUCTX24814311
- UDI
- To be provided, Mfg. Lot/
- Serial #
- t Available; System ID Number 832CT000230
- UDI
- (01)00195278460271(11)240400(21)AEGGL2400004YC, Mfg. Lot/
- Serial #
- AEGGL2400004YC; System ID Number AUCTX24566130
- UDI
- (01)00195278460271(11)241000(21)CBGMG2400005HM, Mfg. Lot/
- Serial #
- CBGMG2400005HM; System ID Number 833CT000211
- UDI
- (01)00195278460271(11)231000(21)REV2X2300080CN, Mfg. Lot/
- Serial #
- REV2X2300080CN; System ID Number AUCTX24493342
- UDI
- To be provided, Mfg. Lot/
- Serial #
- CBGMG2400001HM; System ID Number AUCTX24493214
- UDI
- To be provided, Mfg. Lot/
- Serial #
- CBGMG2400003HM; System ID Number AUCTX24491472
- UDI
- To be provided, Mfg. Lot/
- Serial #
- CBGMG2400004HM; System ID Number 833CT000155
- UDI
- (01)00195278460271(11)240500(21)REV2X2400053CN, Mfg. Lot/
- Serial #
- REV2X2400053CN; System ID Number AH4001CT06
- UDI
- (01)00195278460271(11)240500(21)REV2X2300054CN, Mfg. Lot/
- Serial #
- REV2X2300054CN; System ID Number AH1923CT01
- UDI
- (01)00195278460271(11)240300(21)REV2X2400024CN, Mfg. Lot/
- Serial #
- REV2X2400024CN; System ID Number 140024CT04
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2A2200013CN; System ID Number 220826CT05
- UDI
- (01)00195278460271(11)240100(21)REV2X2400002CN, Mfg. Lot/
- Serial #
- REV2X2400002CN; System ID Number 110094CT02
- UDI
- (01)00195278460271(11)230500(21)REV2X2300011CN, Mfg. Lot/
- Serial #
- REV2X2300011CN; System ID Number 441239APEX1
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400166CN; System ID Number REV2X2400004CN
- UDI
- (01)00195278460271(11)240100(21)REV2X2400004CN, Mfg. Lot/
- Serial #
- REV2X2400004CN; System ID Number REV2X2400076CN
- UDI
- (01)00195278460271(11)240600(21)REV2X2400076CN, Mfg. Lot/
- Serial #
- REV2X2400076CN; System ID Number 12906848
- UDI
- (01)00195278460271(11)241100(21)REV2X2400140CN, Mfg. Lot/
- Serial #
- REV2X2400140CN; System ID Number BG4549CT04
- UDI
- (01)00195278460271(11)230600(21)REV2X2300026CN, Mfg. Lot/
- Serial #
- REV2X2300026CN; System ID Number 604557APEXRT1
- UDI
- (01)00195278460271(11)241000(21)REV2X2400133CN, Mfg. Lot/
- Serial #
- REV2X2400133CN; System ID Number 250635APEX
- UDI
- (01)00195278460271(11)240400(21)REV2X2400045CN, Mfg. Lot/
- Serial #
- REV2X2400045CN; System ID Number 5349227CT11
- UDI
- (01)00195278460271(11)240300(21)REV2X2400022CN, Mfg. Lot/
- Serial #
- REV2X2400022CN; System ID Number 867975APEX
- UDI
- (01)00195278460271(11)240500(21)REV2X2400047CN, Mfg. Lot/
- Serial #
- REV2X2400047CN; System ID Number 905522REVCT1
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400056CN; System ID Number 905522REVCT2
- UDI
- (01)00195278460271(11)241200(21)REV2X2400157CN, Mfg. Lot/
- Serial #
- REV2X2400157CN; System ID Number E416249APEXCTE
- UDI
- (01)00195278460271(11)231100(21)REV2X2300087CN, Mfg. Lot/
- Serial #
- REV2X2300087CN; System ID Number E416249APEXCT2
- UDI
- (01)00195278460271(11)240500(21)REV2X2400052CN, Mfg. Lot/
- Serial #
- REV2X2400052CN; System ID Number E416249APEXCT1
- UDI
- (01)00195278460271(11)240700(21)REV2X2400089CN, Mfg. Lot/
- Serial #
- REV2X2400089CN; System ID Number 705522REVCT2
- UDI
- (01)00195278460271(11)240300(21)REV2X2400029CN, Mfg. Lot/
- Serial #
- REV2X2400029CN; System ID Number APEX160CMEXZ01
- UDI
- To be provided, Mfg. Lot/
- Serial #
- CBFCG2300002HM; System ID Number 12044778
- UDI
- (01)00195278460271(11)240800(21)REV2X2400073CN, Mfg. Lot/
- Serial #
- REV2X2400073CN; System ID Number DK1039CT02
- UDI
- (01)00195278460271(11)230600(21)REV2X2300027CN, Mfg. Lot/
- Serial #
- REV2X2300027CN; System ID Number DK1106CT02
- UDI
- (01)00195278460271(11)230900(21)REV2X2300055CN, Mfg. Lot/
- Serial #
- REV2X2300055CN; System ID Number DK1066CT01
- UDI
- (01)00195278460271(11)221100(21)REV2X2200001CN, Mfg. Lot/
- Serial #
- REV2X2200001CN; System ID Number DK1009CT01
- UDI
- (01)00195278460271(11)221200(21)REV2X2200002CN, Mfg. Lot/
- Serial #
- REV2X2200002CN; System ID Number CT52261701
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2300050CN; System ID Number FI1003CT14
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400164CN; System ID Number 09974427
- UDI
- (01)00195278460271(11)240800(21)REV2X2400094CN, Mfg. Lot/
- Serial #
- REV2X2400094CN; System ID Number 12107537
- UDI
- (01)00195278460271(11)240700(21)REV2X2400090CN, Mfg. Lot/
- Serial #
- REV2X2400090CN; System ID Number 08089969
- UDI
- (01)00195278460271(11)230400(21)REV2X2300004CN, Mfg. Lot/
- Serial #
- REV2X2300004CN; System ID Number 11525316
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400082CN; System ID Number 11379817
- UDI
- (01)00195278460271(11)240700(21)REV2X2400084CN, Mfg. Lot/
- Serial #
- REV2X2400084CN; System ID Number 259056CT01
- UDI
- (01)00195278460271(11)230800(21)REV2X2300051CN, Mfg. Lot/
- Serial #
- REV2X2300051CN; System ID Number HU1766CT01
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400096CN; System ID Number 12743158
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400058CN; System ID Number 083021862540324
- UDI
- (01)00195278460271(11)240800(21)REV2X2400101CN, Mfg. Lot/
- Serial #
- REV2X2400101CN; System ID Number 7982CT0354
- UDI
- (01)00195278460271(11)240200(21)REV2X2400011CN, Mfg. Lot/
- Serial #
- REV2X2400011CN; System ID Number 7982CT0360
- UDI
- (01)00195278460271(11)240100(21)REV2X2400005CN, Mfg. Lot/
- Serial #
- REV2X2400005CN; System ID Number 11960464
- UDI
- (01)00195278460271(11)240800(21)REV2X2400099CN, Mfg. Lot/
- Serial #
- REV2X2400099CN; System ID Number 08876643
- UDI
- (01)00195278460271(11)230700(21)REV2X2300037CN, Mfg. Lot/
- Serial #
- REV2X2300037CN; System ID Number 10025899
- UDI
- (01)00195278460271(11)240200(21)REV2X2400016CN, Mfg. Lot/
- Serial #
- REV2X2400016CN; System ID Number 08867431
- UDI
- (01)00195278460271(11)231000(21)REV2X2300078CN, Mfg. Lot/
- Serial #
- REV2X2300078CN; System ID Number 09897949
- UDI
- (01)00195278460271(11)240700(21)REV2X2400092CN, Mfg. Lot/
- Serial #
- REV2X2400092CN; System ID Number 12128152
- UDI
- To be provided, Mfg. Lot/
- Serial #
- t Available; System ID Number CT00442
- UDI
- (01)00195278460271(11)230600(21)REV2X2300017CN, Mfg. Lot/
- Serial #
- REV2X2300017CN; System ID Number CT00494
- UDI
- (01)00195278460271(11)231000(21)REV2X2300070CN, Mfg. Lot/
- Serial #
- REV2X2300070CN; System ID Number CT00495
- UDI
- (01)00195278460271(11)231000(21)AEGGL2300001YC, Mfg. Lot/
- Serial #
- AEGGL2300001YC; System ID Number CT00639
- UDI
- To be provided, Mfg. Lot/
- Serial #
- t Available; System ID Number CT00638
- UDI
- (01)00195278460271(11)241100(21)CBGMG2400008HM, Mfg. Lot/
- Serial #
- CBGMG2400008HM; System ID Number CT00468
- UDI
- (01)00195278460271(11)240400(21)AEGGL2400005YC, Mfg. Lot/
- Serial #
- AEGGL2400005YC; System ID Number CT00381
- UDI
- (01)00195278460271(11)221100(21)REV2X2200003CN, Mfg. Lot/
- Serial #
- REV2X2200003CN; System ID Number CT00611
- UDI
- (01)00195278460271(11)240700(21)AEGGL2400009YC, Mfg. Lot/
- Serial #
- AEGGL2400009YC; System ID Number CT00637
- UDI
- (01)00195278460271(11)241100(21)CBGMG2400013HM, Mfg. Lot/
- Serial #
- CBGMG2400013HM; System ID Number CT00488
- UDI
- (01)00195278460271(11)231100(21)AEGGL2300002YC, Mfg. Lot/
- Serial #
- AEGGL2300002YC; System ID Number CT00496
- UDI
- To be provided, Mfg. Lot/
- Serial #
- AEGGL2300006YC; System ID Number CT00457
- UDI
- (01)00195278460271(11)230900(21)REV2X2300052CN, Mfg. Lot/
- Serial #
- REV2X2300052CN; System ID Number CT00515
- UDI
- To be provided, Mfg. Lot/
- Serial #
- AEGGL2300004YC; System ID Number CT00516
- UDI
- (01)00195278460271(11)231200(21)AEGGL2300007YC, Mfg. Lot/
- Serial #
- AEGGL2300007YC; System ID Number CT00552
- UDI
- (01)00195278460271(11)240200(21)AEGGL2400003YC, Mfg. Lot/
- Serial #
- AEGGL2400003YC; System ID Number CT00460
- UDI
- (01)00195278460271(11)231100(21)AEGGL2300003YC, Mfg. Lot/
- Serial #
- AEGGL2300003YC; System ID Number CT00486
- UDI
- (01)00195278460271(11)231000(21)REV2X2300079CN, Mfg. Lot/
- Serial #
- REV2X2300079CN; System ID Number KRCT54972221
- UDI
- To be provided, Mfg. Lot/
- Serial #
- t Available; System ID Number KRCT54893311
- UDI
- To be provided, Mfg. Lot/
- Serial #
- t Available; System ID Number KRCT54358591
- UDI
- To be provided, Mfg. Lot/
- Serial #
- AEGGL2400010YC; System ID Number KRCT54358601
- UDI
- To be provided, Mfg. Lot/
- Serial #
- AEGGL2400013YC; System ID Number 0850211084
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2300016CN; System ID Number KRCT54933611
- UDI
- To be provided, Mfg. Lot/
- Serial #
- AEGGL2400014YC; System ID Number 0850211108
- UDI
- (01)00195278460271(11)231200(21)REV2X2300092CN, Mfg. Lot/
- Serial #
- REV2X2300092CN; System ID Number 0850211121
- UDI
- (01)00195278460271(11)240600(21)REV2X2400066CN, Mfg. Lot/
- Serial #
- REV2X2400066CN; System ID Number 0850211094
- UDI
- (01)00195278460271(11)230800(21)REV2X2300048CN, Mfg. Lot/
- Serial #
- REV2X2300048CN; System ID Number 110807CT06
- UDI
- (01)00195278460271(11)241200(21)REV2X2400162CN, Mfg. Lot/
- Serial #
- REV2X2400162CN; System ID Number 0828210145
- UDI
- (01)00195278460271(11)231000(21)REV2X2300073CN, Mfg. Lot/
- Serial #
- REV2X2300073CN; System ID Number LWD0320
- UDI
- (01)00195278460271(11)230700(21)REV2X2300032CN, Mfg. Lot/
- Serial #
- REV2X2300032CN; System ID Number LWD0324
- UDI
- (01)00195278460271(11)231000(21)REV2X2300069CN, Mfg. Lot/
- Serial #
- REV2X2300069CN; System ID Number 859CT000226
- UDI
- (01)00195278460271(11)240400(21)REV2X2400042CN, Mfg. Lot/
- Serial #
- REV2X2400042CN; System ID Number 859CT000190
- UDI
- (01)00195278460271(11)230900(21)REV2X2300053CN, Mfg. Lot/
- Serial #
- REV2X2300053CN; System ID Number NO1043CT05
- UDI
- (01)00195278460271(11)240400(21)REV2X2300047CN, Mfg. Lot/
- Serial #
- REV2X2300047CN; System ID Number NO1043CT04
- UDI
- (01)00195278460271(11)240500(21)REV2X2400048CN, Mfg. Lot/
- Serial #
- REV2X2400048CN; System ID Number 1557CT0318
- UDI
- (01)00195278460271(11)240500(21)REV2X2400057CN, Mfg. Lot/
- Serial #
- REV2X2400057CN; System ID Number P00652CT01
- UDI
- (01)00195278460271(11)240200(21)REV2X2400017CN, Mfg. Lot/
- Serial #
- REV2X2400017CN; System ID Number 600042CT07
- UDI
- (01)00195278460271(11)240500(21)REV2X2400049CN, Mfg. Lot/
- Serial #
- REV2X2400049CN; System ID Number PPR590118
- UDI
- (01)00195278460271(11)240100(21)REV2X2300099CN, Mfg. Lot/
- Serial #
- REV2X2300099CN; System ID Number SA2980CT01
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X23000029CN; System ID Number SA2973CT01
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X23000030CN; System ID Number CT53972381
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400121CN; System ID Number SGCT54294581
- UDI
- (01)00195278460271(11)240600(21)AEGGL2400007YC, Mfg. Lot/
- Serial #
- AEGGL2400007YC; System ID Number 6073CT0103
- UDI
- (01)00195278460271(11)240200(21)REV2X2400010CN, Mfg. Lot/
- Serial #
- REV2X2400010CN; System ID Number SGCTX24467795
- UDI
- (01)00195278460271(11)240700(21)REV2X2400087CN, Mfg. Lot/
- Serial #
- REV2X2400087CN; System ID Number SGCTX24467793
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400102CN; System ID Number 12622329
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400165CN; System ID Number P002CT03
- UDI
- (01)00195278460271(11)230800(21)REV2X2300045CN, Mfg. Lot/
- Serial #
- REV2X2300045CN; System ID Number L007CT02
- UDI
- (01)00195278460271(11)231200(21)REV2X2300093CN, Mfg. Lot/
- Serial #
- REV2X2300093CN; System ID Number O009CT06
- UDI
- (01)00195278460271(11)230500(21)REV2X2300010CN, Mfg. Lot/
- Serial #
- REV2X2300010CN; System ID Number M007CT03
- UDI
- (01)00195278460271(11)230800(21)REV2X2300043CN, Mfg. Lot/
- Serial #
- REV2X2300043CN; System ID Number L001CT01
- UDI
- (01)00195278460271(11)240100(21)REV2X2300098CN, Mfg. Lot/
- Serial #
- REV2X2300098CN; System ID Number M001CT04
- UDI
- (01)00195278460271(11)230700(21)REV2X2300034CN, Mfg. Lot/
- Serial #
- REV2X2300034CN; System ID Number M001CT02
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400003CN; System ID Number M001CT06
- UDI
- To be provided, Mfg. Lot/
- Serial #
- t Available; System ID Number M004CT02
- UDI
- (01)00195278460271(11)230400(21)REV2X2300005CN, Mfg. Lot/
- Serial #
- REV2X2300005CN; System ID Number R002CT12
- UDI
- (01)00195278460271(11)230500(21)REV2X2300012CN, Mfg. Lot/
- Serial #
- REV2X2300012CN; System ID Number A201CT07
- UDI
- (01)00195278460271(11)240200(21)REV2X2400014CN, Mfg. Lot/
- Serial #
- REV2X2400014CN; System ID Number A201CT05
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400130CN; System ID Number 222769CT01
- UDI
- (01)00195278460271(11)231100(21)REV2X2300085CN, Mfg. Lot/
- Serial #
- REV2X2300085CN; System ID Number 529150CT04
- UDI
- (01)00195278460271(11)230600(21)REV2X2300019CN, Mfg. Lot/
- Serial #
- REV2X2300019CN; System ID Number 529150CT02
- UDI
- (01)00195278460271(11)230600(21)REV2X2300023CN, Mfg. Lot/
- Serial #
- REV2X2300023CN; System ID Number 850030CT02
- UDI
- (01)00195278460271(11)230800(21)REV2X2300044CN, Mfg. Lot/
- Serial #
- REV2X2300044CN; System ID Number THCTX24524601
- UDI
- (01)00195278460271(11)241000(21)REV2X2400131CN, Mfg. Lot/
- Serial #
- REV2X2400131CN; System ID Number THCTX24513791
- UDI
- (01)00195278460271(11)240900(21)REV2X2400120CN, Mfg. Lot/
- Serial #
- REV2X2400120CN; System ID Number THCTX24476143
- UDI
- (01)00195278460271(11)241000(21)REV2X2400125CN, Mfg. Lot/
- Serial #
- REV2X2400125CN; System ID Number 12338981
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400159CN; System ID Number 10127416
- UDI
- (01)00195278460271(11)240300(21)REV2X2400031CN, Mfg. Lot/
- Serial #
- REV2X2400031CN; System ID Number 09850616
- UDI
- (01)00195278460271(11)240300(21)REV2X2400025CN, Mfg. Lot/
- Serial #
- REV2X2400025CN; System ID Number 09993031
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400012CN; System ID Number 10396521
- UDI
- (01)00195278460271(11)240400(21)REV2X2400040CN, Mfg. Lot/
- Serial #
- REV2X2400040CN; System ID Number 09904040
- UDI
- (01)00195278460271(11)240100(21)REV2X2400007CN, Mfg. Lot/
- Serial #
- REV2X2400007CN; System ID Number 10493318
- UDI
- (01)00195278460271(11)240400(21)REV2X2400037CN, Mfg. Lot/
- Serial #
- REV2X2400037CN; System ID Number 09526282
- UDI
- (01)00195278460271(11)241100(21)REV2X2400145CN, Mfg. Lot/
- Serial #
- REV2X2400145CN; System ID Number 10127401
- UDI
- (01)00195278460271(11)240200(21)REV2X2400018CN, Mfg. Lot/
- Serial #
- REV2X2400018CN; System ID Number 10131630
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400020CN; System ID Number 10231464
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2500002CN; System ID Number 9830CT0444
- UDI
- (01)00195278460271(11)240700(21)REV2X2400083CN, Mfg. Lot/
- Serial #
- REV2X2400083CN; System ID Number VNCTX24476164
- UDI
- (01)00195278460271(11)240800(21)REV2X2400103CN, Mfg. Lot/
- Serial #
- REV2X2400103CN; System ID Number VNCT5320632A
- UDI
- (01)00195278460271(11)240400(21)REV2X2400036CN, Mfg. Lot/
- Serial #
- REV2X2400036CN; System ID Number VNCTX24515754
- UDI
- (01)00195278460271(11)240900(21)REV2X2400122CN, Mfg. Lot/
- Serial #
- REV2X2400122CN
Show 490 more code fieldsShow fewer
What the firm is doing
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/18/2025 via letter delivered using a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken: "You can continue to use your system. Please monitor the floor near the base of the gantry for any accumulation of blue fluid. If blue fluid is observed, wear nitrile or rubber gloves, clean up the fluid by absorbing it with a noncombustible absorbent material, and dispose of the absorbent material in a suitable container for disposal. Please contact your local GE HealthCare service representative if any blue fluid is observed. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please complete and return the attached acknowledgement form to recall.25504@gehealthcare.com."
DistributionShow detailsHide
Worldwide distribution.
Class IIWhat this means
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1298-2025
- FDA 510(k) clearance · K213715The device's official FDA premarket clearance record
- FDA device classification · JAKOfficial FDA classification for this device type
- CFR regulation · 21 CFR 892.1750The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find GE Medical Systems, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus
Legal News Analyst
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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