GE Healthcare Revolution CT, System, X-ray, Tomography, Computed

Class I - Dangerous

🏥 Medical Devices Recalled: February 18, 2025 GE Medical Systems Other Medical Devices

What Should You Do?

Check if you have this product:
System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number 480342APEX, UDI (01)00840682146616(11)220900(21)REV2A2200072CN, Mfg. Lot/Serial Number REV2A2200072CN; 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 858657APEX, UDI (01)00840682118552(11)160900(21)REVVX1600034CN, Mfg. Lot/Serial Number REVVX1600034CN; System ID Number 310423CT, UDI (01)00840682118552(11)211200(21)REVVX2100047CN, Mfg. Lot/Serial Number REVVX2100047CN; System ID Number 707257APEX1, UDI (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/Serial Number REV2X2300077CN; System ID Number 650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN; System ID Number 408559CTREVO, UDI To be provided, Mfg. Lot/Serial Number REVV81900011CN; System ID Number 904UFNAPEX, UDI (01)00195278460271(11)230300(21)REV2X2300001CN, Mfg. Lot/Serial Number REV2X2300001CN; 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 808522RCT, UDI Not Applicable, Mfg. Lot/Serial Number 00000441716CN8; 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 718334CTREV, UDI (01)00840682146616(11)220700(21)REV2A2200050CN, Mfg. Lot/Serial Number REV2A2200050CN; System ID Number 765298APEX2, UDI (01)00195278502179(11)241000(21)REV282400043CN, Mfg. Lot/Serial Number REV282400043CN; 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 508971REV, UDI (01)00195278460271(11)241000(21)REV2X2400124CN, Mfg. Lot/Serial Number REV2X2400124CN; System ID Number 413794APCT, UDI (01)00840682146616(11)210800(21)REV2A2100036CN, Mfg. Lot/Serial Number REV2A2100036CN; System ID Number 980993CT1, UDI (01)00840682146616(11)210700(21)REV2A2100029CN, Mfg. Lot/Serial Number REV2A2100029CN; System ID Number 973971REV160, UDI (01)00840682146616(11)200600(21)REV2A2000015CN, Mfg. Lot/Serial Number REV2A2000015CN; System ID Number 702961PCT, UDI (01)00195278460271(11)230900(21)REV2X2300063CN, Mfg. Lot/Serial Number REV2X2300063CN; System ID Number 646962APEX1, UDI To be provided, Mfg. Lot/Serial Number REV242200002CN; System ID Number 516MHCTED1, UDI (01)00195278460271(11)231200(21)REV2X2300090CN, Mfg. Lot/Serial Number REV2X2300090CN; System ID Number COR526548, UDI (01)00840682118552(11)160700(21)REVVX1600013CN, Mfg. Lot/Serial Number REVVX1600013CN; System ID Number 718226VZAPEX, UDI (01)00195278460271(11)230500(21)REV2X2300009CN, Mfg. Lot/Serial Number REV2X2300009CN; System ID Number 330480APEX1, UDI (01)00195278460271(11)240900(21)REV2X2400113CN, Mfg. Lot/Serial Number REV2X2400113CN; System ID Number 864725APEX2, UDI (01)00195278460271(11)230700(21)REV2X2300040CN, Mfg. Lot/Serial Number REV2X2300040CN; System ID Number 985NODCAPEX, UDI (01)00840682146616(11)221200(21)REV2A2200119CN, Mfg. Lot/Serial Number REV2A2200119CN; System ID Number 615936REVO, UDI (01)00840682118552(11)181000(21)REVVX1800108CN, Mfg. Lot/Serial Number REVVX1800108CN; System ID Number 713790APEX, UDI (01)00195278460271(11)230900(21)REV2X2300060CN, Mfg. Lot/Serial Number REV2X2300060CN; System ID Number 210757APEX, UDI (01)00195278460271(11)230800(21)REV2X2300049CN, Mfg. Lot/Serial Number REV2X2300049CN; System ID Number 713442APEX, UDI (01)00195278460271(11)230700(21)REV2X2300036CN, Mfg. Lot/Serial Number REV2X2300036CN; System ID Number 703776APEX1, UDI (01)00840682146616(11)221100(21)REV2A2200105CN, Mfg. Lot/Serial Number REV2A2200105CN; System ID Number 425688REV, UDI (01)00195278460271(11)241000(21)REV2X2400132CN, Mfg. Lot/Serial Number REV2X2400132CN; System ID Number 206320REV2, UDI To be provided, Mfg. Lot/Serial Number REVV82200025CN; System ID Number 206668REV, UDI To be provided, Mfg. Lot/Serial Number REVV82200045CN; System ID Number 608890APEXELITE, UDI (01)00195278460271(11)240700(21)REV2X2400081CN, Mfg. Lot/Serial Number REV2X2400081CN; System ID Number 608263REVCT, UDI Not Applicable, Mfg. Lot/Serial Number 00000443379CN3; System ID Number 414805IPCT, UDI (01)00840682118552(11)180500(21)REVVX1800047CN, Mfg. Lot/Serial Number REVVX1800047CN; System ID Number 262577REVCT, UDI (01)00195278460271(11)240500(21)REV2X2400055CN, Mfg. Lot/Serial Number REV2X2400055CN; System ID Number 83195527023, UDI (01)00840682146616(11)200400(21)REV2A2000010CN, Mfg. Lot/Serial Number REV2A2000010CN; 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 83155841562, UDI To be provided, Mfg. Lot/Serial Number REVVX1600011CN; 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 030355CT07, UDI To be provided, Mfg. Lot/Serial Number 441578CN2; System ID Number 190059CT07, UDI (01)00840682146616(11)211200(21)REV2A2100053CN, Mfg. Lot/Serial Number REV2A2100053CN; System ID Number 030005CT04, UDI (01)00840682118552(11)211100(21)REVVX2100043CN, Mfg. Lot/Serial Number REVVX2100043CN; System ID Number 12906848, UDI (01)00195278460271(11)241100(21)REV2X2400140CN, Mfg. Lot/Serial Number REV2X2400140CN; System ID Number 250635APEX, UDI (01)00195278460271(11)240400(21)REV2X2400045CN, Mfg. Lot/Serial Number REV2X2400045CN; System ID Number 204726RCT, UDI (01)00840682146616(11)200600(21)REV2A2000017CN, Mfg. Lot/Serial Number REV2A2000017CN; System ID Number DK1547CT02, UDI (01)00840682146616(11)210100(21)REV2A2100002CN, Mfg. Lot/Serial Number REV2A2100002CN; System ID Number DK1106CT02, UDI (01)00195278460271(11)230900(21)REV2X2300055CN, Mfg. Lot/Serial Number REV2X2300055CN; System ID Number DK1009CT01, UDI (01)00195278460271(11)221200(21)REV2X2200002CN, Mfg. Lot/Serial Number REV2X2200002CN; System ID Number FI1003CT14, UDI To be provided, Mfg. Lot/Serial Number REV2X2400164CN; System ID Number 06405034, UDI (01)00840682146616(11)220500(21)REV2A2200029CN, Mfg. Lot/Serial Number REV2A2200029CN; System ID Number C4193357, UDI (01)00840682146616(11)210800(21)REV2A2100033CN, Mfg. Lot/Serial Number REV2A2100033CN; System ID Number X143039508, UDI (01)00840682118552(11)170700(21)REVVX1700074CN, Mfg. Lot/Serial Number REVVX1700074CN; System ID Number 07272697, UDI (01)00840682146616(11)220600(21)REV2A2200046CN, Mfg. Lot/Serial Number REV2A2200046CN; 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 11437190, UDI To be provided, Mfg. Lot/Serial Number CBGLG2400001HM; 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 13043139, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number A5624142, UDI To be provided, Mfg. Lot/Serial Number 00000440478CN6; 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 A5582819, UDI (01)00840682118552(11)170100(21)REVVX1700004CN, Mfg. Lot/Serial Number REVVX1700004CN; System ID Number 09897949, UDI (01)00195278460271(11)240700(21)REV2X2400092CN, Mfg. Lot/Serial Number REV2X2400092CN; System ID Number A5605766, UDI (01)00840682146319(11)240800(21)KITNH2400036CN, Mfg. Lot/Serial Number REVVX1900047CN; System ID Number REV075, UDI (01)00840682118552(11)190400(21)REVVX1900046CN, Mfg. Lot/Serial Number REVVX1900046CN; System ID Number CT00494, UDI (01)00195278460271(11)231000(21)REV2X2300070CN, Mfg. Lot/Serial Number REV2X2300070CN; 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 REV072, UDI (01)00840682118552(11)190400(21)REGGL1900004YC, Mfg. Lot/Serial Number REGGL1900004YC; System ID Number CT00488, UDI (01)00195278460271(11)231100(21)AEGGL2300002YC, Mfg. Lot/Serial Number AEGGL2300002YC; System ID Number CT00516, UDI (01)00195278460271(11)231200(21)AEGGL2300007YC, Mfg. Lot/Serial Number AEGGL2300007YC; System ID Number KRCT54358591, UDI To be provided, Mfg. Lot/Serial Number AEGGL2400010YC; 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 0850210965, UDI (01)00840682123471(11)190600(21)REVV81900021CN, Mfg. Lot/Serial Number REVV81900021CN; System ID Number KW1018CT05, UDI (01)00840682118552(11)170300(21)REVVX1700034CN, Mfg. Lot/Serial Number REVVX1700034CN; 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 6073CT0095, UDI (01)00840682146616(11)230900(21)REV2A2300043CN, Mfg. Lot/Serial Number REV2A2300043CN; 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 R002CT10, UDI (01)00840682123471(11)180200(21)REVV81800003CN, Mfg. Lot/Serial Number REVV81800003CN; System ID Number O005CT14, UDI (01)00840682146616(11)200400(21)REV2A2000009CN, Mfg. Lot/Serial Number REV2A2000009CN; 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 1573CT0126, UDI (01)00840682146616(11)220100(21)REV2A2200002CN, Mfg. Lot/Serial Number REV2A2200002CN; System ID Number THCTX24476143, UDI (01)00195278460271(11)241000(21)REV2X2400125CN, Mfg. Lot/Serial Number REV2X2400125CN; System ID Number 08124357, UDI (01)00840682146616(11)230400(21)REV2A2300024CN, Mfg. Lot/Serial Number REV2A2300024CN; System ID Number 09904040, UDI (01)00195278460271(11)240100(21)REV2X2400007CN, Mfg. Lot/Serial Number REV2X2400007CN; System ID Number 10231464, UDI To be provided, Mfg. Lot/Serial Number REV2X2500002CN
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: GE Medical Systems, LLC
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

GE Healthcare Revolution CT, System, X-ray, Tomography, Computed

Product Codes/Lot Numbers:

System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number 480342APEX, UDI (01)00840682146616(11)220900(21)REV2A2200072CN, Mfg. Lot/Serial Number REV2A2200072CN; 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 858657APEX, UDI (01)00840682118552(11)160900(21)REVVX1600034CN, Mfg. Lot/Serial Number REVVX1600034CN; System ID Number 310423CT, UDI (01)00840682118552(11)211200(21)REVVX2100047CN, Mfg. Lot/Serial Number REVVX2100047CN; System ID Number 707257APEX1, UDI (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/Serial Number REV2X2300077CN; System ID Number 650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN; System ID Number 408559CTREVO, UDI To be provided, Mfg. Lot/Serial Number REVV81900011CN; System ID Number 904UFNAPEX, UDI (01)00195278460271(11)230300(21)REV2X2300001CN, Mfg. Lot/Serial Number REV2X2300001CN; 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 808522RCT, UDI Not Applicable, Mfg. Lot/Serial Number 00000441716CN8; 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 718334CTREV, UDI (01)00840682146616(11)220700(21)REV2A2200050CN, Mfg. Lot/Serial Number REV2A2200050CN; System ID Number 765298APEX2, UDI (01)00195278502179(11)241000(21)REV282400043CN, Mfg. Lot/Serial Number REV282400043CN; 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 508971REV, UDI (01)00195278460271(11)241000(21)REV2X2400124CN, Mfg. Lot/Serial Number REV2X2400124CN; System ID Number 413794APCT, UDI (01)00840682146616(11)210800(21)REV2A2100036CN, Mfg. Lot/Serial Number REV2A2100036CN; System ID Number 980993CT1, UDI (01)00840682146616(11)210700(21)REV2A2100029CN, Mfg. Lot/Serial Number REV2A2100029CN; System ID Number 973971REV160, UDI (01)00840682146616(11)200600(21)REV2A2000015CN, Mfg. Lot/Serial Number REV2A2000015CN; System ID Number 702961PCT, UDI (01)00195278460271(11)230900(21)REV2X2300063CN, Mfg. Lot/Serial Number REV2X2300063CN; System ID Number 646962APEX1, UDI To be provided, Mfg. Lot/Serial Number REV242200002CN; System ID Number 516MHCTED1, UDI (01)00195278460271(11)231200(21)REV2X2300090CN, Mfg. Lot/Serial Number REV2X2300090CN; System ID Number COR526548, UDI (01)00840682118552(11)160700(21)REVVX1600013CN, Mfg. Lot/Serial Number REVVX1600013CN; System ID Number 718226VZAPEX, UDI (01)00195278460271(11)230500(21)REV2X2300009CN, Mfg. Lot/Serial Number REV2X2300009CN; System ID Number 330480APEX1, UDI (01)00195278460271(11)240900(21)REV2X2400113CN, Mfg. Lot/Serial Number REV2X2400113CN; System ID Number 864725APEX2, UDI (01)00195278460271(11)230700(21)REV2X2300040CN, Mfg. Lot/Serial Number REV2X2300040CN; System ID Number 985NODCAPEX, UDI (01)00840682146616(11)221200(21)REV2A2200119CN, Mfg. Lot/Serial Number REV2A2200119CN; System ID Number 615936REVO, UDI (01)00840682118552(11)181000(21)REVVX1800108CN, Mfg. Lot/Serial Number REVVX1800108CN; System ID Number 713790APEX, UDI (01)00195278460271(11)230900(21)REV2X2300060CN, Mfg. Lot/Serial Number REV2X2300060CN; System ID Number 210757APEX, UDI (01)00195278460271(11)230800(21)REV2X2300049CN, Mfg. Lot/Serial Number REV2X2300049CN; System ID Number 713442APEX, UDI (01)00195278460271(11)230700(21)REV2X2300036CN, Mfg. Lot/Serial Number REV2X2300036CN; System ID Number 703776APEX1, UDI (01)00840682146616(11)221100(21)REV2A2200105CN, Mfg. Lot/Serial Number REV2A2200105CN; System ID Number 425688REV, UDI (01)00195278460271(11)241000(21)REV2X2400132CN, Mfg. Lot/Serial Number REV2X2400132CN; System ID Number 206320REV2, UDI To be provided, Mfg. Lot/Serial Number REVV82200025CN; System ID Number 206668REV, UDI To be provided, Mfg. Lot/Serial Number REVV82200045CN; System ID Number 608890APEXELITE, UDI (01)00195278460271(11)240700(21)REV2X2400081CN, Mfg. Lot/Serial Number REV2X2400081CN; System ID Number 608263REVCT, UDI Not Applicable, Mfg. Lot/Serial Number 00000443379CN3; System ID Number 414805IPCT, UDI (01)00840682118552(11)180500(21)REVVX1800047CN, Mfg. Lot/Serial Number REVVX1800047CN; System ID Number 262577REVCT, UDI (01)00195278460271(11)240500(21)REV2X2400055CN, Mfg. Lot/Serial Number REV2X2400055CN; System ID Number 83195527023, UDI (01)00840682146616(11)200400(21)REV2A2000010CN, Mfg. Lot/Serial Number REV2A2000010CN; 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 83155841562, UDI To be provided, Mfg. Lot/Serial Number REVVX1600011CN; 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 030355CT07, UDI To be provided, Mfg. Lot/Serial Number 441578CN2; System ID Number 190059CT07, UDI (01)00840682146616(11)211200(21)REV2A2100053CN, Mfg. Lot/Serial Number REV2A2100053CN; System ID Number 030005CT04, UDI (01)00840682118552(11)211100(21)REVVX2100043CN, Mfg. Lot/Serial Number REVVX2100043CN; System ID Number 12906848, UDI (01)00195278460271(11)241100(21)REV2X2400140CN, Mfg. Lot/Serial Number REV2X2400140CN; System ID Number 250635APEX, UDI (01)00195278460271(11)240400(21)REV2X2400045CN, Mfg. Lot/Serial Number REV2X2400045CN; System ID Number 204726RCT, UDI (01)00840682146616(11)200600(21)REV2A2000017CN, Mfg. Lot/Serial Number REV2A2000017CN; System ID Number DK1547CT02, UDI (01)00840682146616(11)210100(21)REV2A2100002CN, Mfg. Lot/Serial Number REV2A2100002CN; System ID Number DK1106CT02, UDI (01)00195278460271(11)230900(21)REV2X2300055CN, Mfg. Lot/Serial Number REV2X2300055CN; System ID Number DK1009CT01, UDI (01)00195278460271(11)221200(21)REV2X2200002CN, Mfg. Lot/Serial Number REV2X2200002CN; System ID Number FI1003CT14, UDI To be provided, Mfg. Lot/Serial Number REV2X2400164CN; System ID Number 06405034, UDI (01)00840682146616(11)220500(21)REV2A2200029CN, Mfg. Lot/Serial Number REV2A2200029CN; System ID Number C4193357, UDI (01)00840682146616(11)210800(21)REV2A2100033CN, Mfg. Lot/Serial Number REV2A2100033CN; System ID Number X143039508, UDI (01)00840682118552(11)170700(21)REVVX1700074CN, Mfg. Lot/Serial Number REVVX1700074CN; System ID Number 07272697, UDI (01)00840682146616(11)220600(21)REV2A2200046CN, Mfg. Lot/Serial Number REV2A2200046CN; 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 11437190, UDI To be provided, Mfg. Lot/Serial Number CBGLG2400001HM; 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 13043139, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number A5624142, UDI To be provided, Mfg. Lot/Serial Number 00000440478CN6; 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 A5582819, UDI (01)00840682118552(11)170100(21)REVVX1700004CN, Mfg. Lot/Serial Number REVVX1700004CN; System ID Number 09897949, UDI (01)00195278460271(11)240700(21)REV2X2400092CN, Mfg. Lot/Serial Number REV2X2400092CN; System ID Number A5605766, UDI (01)00840682146319(11)240800(21)KITNH2400036CN, Mfg. Lot/Serial Number REVVX1900047CN; System ID Number REV075, UDI (01)00840682118552(11)190400(21)REVVX1900046CN, Mfg. Lot/Serial Number REVVX1900046CN; System ID Number CT00494, UDI (01)00195278460271(11)231000(21)REV2X2300070CN, Mfg. Lot/Serial Number REV2X2300070CN; 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 REV072, UDI (01)00840682118552(11)190400(21)REGGL1900004YC, Mfg. Lot/Serial Number REGGL1900004YC; System ID Number CT00488, UDI (01)00195278460271(11)231100(21)AEGGL2300002YC, Mfg. Lot/Serial Number AEGGL2300002YC; System ID Number CT00516, UDI (01)00195278460271(11)231200(21)AEGGL2300007YC, Mfg. Lot/Serial Number AEGGL2300007YC; System ID Number KRCT54358591, UDI To be provided, Mfg. Lot/Serial Number AEGGL2400010YC; 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 0850210965, UDI (01)00840682123471(11)190600(21)REVV81900021CN, Mfg. Lot/Serial Number REVV81900021CN; System ID Number KW1018CT05, UDI (01)00840682118552(11)170300(21)REVVX1700034CN, Mfg. Lot/Serial Number REVVX1700034CN; 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 6073CT0095, UDI (01)00840682146616(11)230900(21)REV2A2300043CN, Mfg. Lot/Serial Number REV2A2300043CN; 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 R002CT10, UDI (01)00840682123471(11)180200(21)REVV81800003CN, Mfg. Lot/Serial Number REVV81800003CN; System ID Number O005CT14, UDI (01)00840682146616(11)200400(21)REV2A2000009CN, Mfg. Lot/Serial Number REV2A2000009CN; 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 1573CT0126, UDI (01)00840682146616(11)220100(21)REV2A2200002CN, Mfg. Lot/Serial Number REV2A2200002CN; System ID Number THCTX24476143, UDI (01)00195278460271(11)241000(21)REV2X2400125CN, Mfg. Lot/Serial Number REV2X2400125CN; System ID Number 08124357, UDI (01)00840682146616(11)230400(21)REV2A2300024CN, Mfg. Lot/Serial Number REV2A2300024CN; System ID Number 09904040, UDI (01)00195278460271(11)240100(21)REV2X2400007CN, Mfg. Lot/Serial Number REV2X2400007CN; System ID Number 10231464, UDI To be provided, Mfg. Lot/Serial Number REV2X2500002CN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1302-2025

Related Recalls

Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

GE Medical Systems

Class I - Dangerous

Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).

Oct 24, 2025 Diagnostic Equipment View Details →

MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4

GE Medical Systems

Class I - Dangerous

If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.

Aug 22, 2025 Other Medical Devices Nationwide View Details →

LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535

GE Medical Systems

Class I - Dangerous

The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.

Sep 18, 2025 Other Medical Devices Nationwide View Details →