{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "212666", "product_res_number": "Z-1302-2025", "event_date_initiated": "2025-02-18", "event_date_posted": "2025-03-07", "recall_status": "Open, Classified", "res_event_number": "96370", "product_code": "JAK", "product_description": "GE Healthcare Revolution CT, System, X-ray, Tomography, Computed", "code_info": "System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; \nSystem ID Number 480342APEX, UDI (01)00840682146616(11)220900(21)REV2A2200072CN, Mfg. Lot/Serial Number REV2A2200072CN; \nSystem ID Number 480342APEX3, UDI (01)00195278460271(11)240600(21)REV2X2400067CN, Mfg. Lot/Serial Number REV2X2400067CN; \nSystem ID Number 949250APEX, UDI (01)00195278460271(11)230500(21)REV2X2300008CN, Mfg. Lot/Serial Number REV2X2300008CN; \nSystem ID Number 858657APEX, UDI (01)00840682118552(11)160900(21)REVVX1600034CN, Mfg. Lot/Serial Number REVVX1600034CN; \nSystem ID Number 310423CT, UDI (01)00840682118552(11)211200(21)REVVX2100047CN, Mfg. Lot/Serial Number REVVX2100047CN; \nSystem ID Number 707257APEX1, UDI (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/Serial Number REV2X2300077CN; \nSystem ID Number 650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN; \nSystem ID Number 408559CTREVO, UDI To be provided, Mfg. Lot/Serial Number REVV81900011CN; \nSystem ID Number 904UFNAPEX, UDI (01)00195278460271(11)230300(21)REV2X2300001CN, Mfg. Lot/Serial Number REV2X2300001CN; \nSystem ID Number 813972APEX2, UDI (01)00195278460271(11)240700(21)REV2X2400088CN, Mfg. Lot/Serial Number REV2X2400088CN; \nSystem ID Number 813972APEX3, UDI (01)00195278460271(11)241000(21)REV2X2400135CN, Mfg. Lot/Serial Number REV2X2400135CN; \nSystem ID Number 808522RCT, UDI Not Applicable, Mfg. Lot/Serial Number 00000441716CN8; \nSystem ID Number 312996CTRV2, UDI (01)00195278460271(11)241000(21)REV2X2400126CN, Mfg. Lot/Serial Number REV2X2400126CN; \nSystem ID Number 708245APEX1, UDI (01)00195278460271(11)230900(21)REV2X2300064CN, Mfg. Lot/Serial Number REV2X2300064CN; \nSystem ID Number 718334CTREV, UDI (01)00840682146616(11)220700(21)REV2A2200050CN, Mfg. Lot/Serial Number REV2A2200050CN; \nSystem ID Number 765298APEX2, UDI (01)00195278502179(11)241000(21)REV282400043CN, Mfg. Lot/Serial Number REV282400043CN; \nSystem ID Number 913588APEX2, UDI (01)00195278460271(11)231200(21)REV2X2300091CN, Mfg. Lot/Serial Number REV2X2300091CN; \nSystem ID Number 270444APEXCT, UDI To be provided, Mfg. Lot/Serial Number REV2X2300083CN; \nSystem ID Number 508971REV, UDI (01)00195278460271(11)241000(21)REV2X2400124CN, Mfg. Lot/Serial Number REV2X2400124CN; \nSystem ID Number 413794APCT, UDI (01)00840682146616(11)210800(21)REV2A2100036CN, Mfg. Lot/Serial Number REV2A2100036CN; \nSystem ID Number 980993CT1, UDI (01)00840682146616(11)210700(21)REV2A2100029CN, Mfg. Lot/Serial Number REV2A2100029CN; \nSystem ID Number 973971REV160, UDI (01)00840682146616(11)200600(21)REV2A2000015CN, Mfg. Lot/Serial Number REV2A2000015CN; \nSystem ID Number 702961PCT, UDI (01)00195278460271(11)230900(21)REV2X2300063CN, Mfg. Lot/Serial Number REV2X2300063CN; \nSystem ID Number 646962APEX1, UDI To be provided, Mfg. Lot/Serial Number REV242200002CN; \nSystem ID Number 516MHCTED1, UDI (01)00195278460271(11)231200(21)REV2X2300090CN, Mfg. Lot/Serial Number REV2X2300090CN; \nSystem ID Number COR526548, UDI (01)00840682118552(11)160700(21)REVVX1600013CN, Mfg. Lot/Serial Number REVVX1600013CN; \nSystem ID Number 718226VZAPEX, UDI (01)00195278460271(11)230500(21)REV2X2300009CN, Mfg. Lot/Serial Number REV2X2300009CN; \nSystem ID Number 330480APEX1, UDI (01)00195278460271(11)240900(21)REV2X2400113CN, Mfg. Lot/Serial Number REV2X2400113CN; \nSystem ID Number 864725APEX2, UDI (01)00195278460271(11)230700(21)REV2X2300040CN, Mfg. Lot/Serial Number REV2X2300040CN; \nSystem ID Number 985NODCAPEX, UDI (01)00840682146616(11)221200(21)REV2A2200119CN, Mfg. Lot/Serial Number REV2A2200119CN; \nSystem ID Number 615936REVO, UDI (01)00840682118552(11)181000(21)REVVX1800108CN, Mfg. Lot/Serial Number REVVX1800108CN; \nSystem ID Number 713790APEX, UDI (01)00195278460271(11)230900(21)REV2X2300060CN, Mfg. Lot/Serial Number REV2X2300060CN; \nSystem ID Number 210757APEX, UDI (01)00195278460271(11)230800(21)REV2X2300049CN, Mfg. Lot/Serial Number REV2X2300049CN; \nSystem ID Number 713442APEX, UDI (01)00195278460271(11)230700(21)REV2X2300036CN, Mfg. Lot/Serial Number REV2X2300036CN; \nSystem ID Number 703776APEX1, UDI (01)00840682146616(11)221100(21)REV2A2200105CN, Mfg. Lot/Serial Number REV2A2200105CN; \nSystem ID Number 425688REV, UDI (01)00195278460271(11)241000(21)REV2X2400132CN, Mfg. Lot/Serial Number REV2X2400132CN; \nSystem ID Number 206320REV2, UDI To be provided, Mfg. Lot/Serial Number REVV82200025CN; \nSystem ID Number 206668REV, UDI To be provided, Mfg. Lot/Serial Number REVV82200045CN; \nSystem ID Number 608890APEXELITE, UDI (01)00195278460271(11)240700(21)REV2X2400081CN, Mfg. Lot/Serial Number REV2X2400081CN; \nSystem ID Number 608263REVCT, UDI Not Applicable, Mfg. Lot/Serial Number 00000443379CN3; \nSystem ID Number 414805IPCT, UDI (01)00840682118552(11)180500(21)REVVX1800047CN, Mfg. Lot/Serial Number REVVX1800047CN; \nSystem ID Number 262577REVCT, UDI (01)00195278460271(11)240500(21)REV2X2400055CN, Mfg. Lot/Serial Number REV2X2400055CN; \nSystem ID Number 83195527023, UDI (01)00840682146616(11)200400(21)REV2A2000010CN, Mfg. Lot/Serial Number REV2A2000010CN; \nSystem ID Number AUCTX24493214, UDI To be provided, Mfg. Lot/Serial Number CBGMG2400003HM; \nSystem ID Number AUCTX24491472, UDI To be provided, Mfg. Lot/Serial Number CBGMG2400004HM; \nSystem ID Number 833CT000155, UDI (01)00195278460271(11)240500(21)REV2X2400053CN, Mfg. Lot/Serial Number REV2X2400053CN; \nSystem ID Number 83155841562, UDI To be provided, Mfg. Lot/Serial Number REVVX1600011CN; \nSystem ID Number AH1923CT01, UDI (01)00195278460271(11)240300(21)REV2X2400024CN, Mfg. Lot/Serial Number REV2X2400024CN; \nSystem ID Number 140024CT04, UDI To be provided, Mfg. Lot/Serial Number REV2A2200013CN; \nSystem ID Number 030355CT07, UDI To be provided, Mfg. Lot/Serial Number 441578CN2; \nSystem ID Number 190059CT07, UDI (01)00840682146616(11)211200(21)REV2A2100053CN, Mfg. Lot/Serial Number REV2A2100053CN; \nSystem ID Number 030005CT04, UDI (01)00840682118552(11)211100(21)REVVX2100043CN, Mfg. Lot/Serial Number REVVX2100043CN; \nSystem ID Number 12906848, UDI (01)00195278460271(11)241100(21)REV2X2400140CN, Mfg. Lot/Serial Number REV2X2400140CN; \nSystem ID Number 250635APEX, UDI (01)00195278460271(11)240400(21)REV2X2400045CN, Mfg. Lot/Serial Number REV2X2400045CN; \nSystem ID Number 204726RCT, UDI (01)00840682146616(11)200600(21)REV2A2000017CN, Mfg. Lot/Serial Number REV2A2000017CN; \nSystem ID Number DK1547CT02, UDI (01)00840682146616(11)210100(21)REV2A2100002CN, Mfg. Lot/Serial Number REV2A2100002CN; \nSystem ID Number DK1106CT02, UDI (01)00195278460271(11)230900(21)REV2X2300055CN, Mfg. Lot/Serial Number REV2X2300055CN; \nSystem ID Number DK1009CT01, UDI (01)00195278460271(11)221200(21)REV2X2200002CN, Mfg. Lot/Serial Number REV2X2200002CN; \nSystem ID Number FI1003CT14, UDI To be provided, Mfg. Lot/Serial Number REV2X2400164CN; \nSystem ID Number 06405034, UDI (01)00840682146616(11)220500(21)REV2A2200029CN, Mfg. Lot/Serial Number REV2A2200029CN; \nSystem ID Number C4193357, UDI (01)00840682146616(11)210800(21)REV2A2100033CN, Mfg. Lot/Serial Number REV2A2100033CN; \nSystem ID Number X143039508, UDI (01)00840682118552(11)170700(21)REVVX1700074CN, Mfg. Lot/Serial Number REVVX1700074CN; \nSystem ID Number 07272697, UDI (01)00840682146616(11)220600(21)REV2A2200046CN, Mfg. Lot/Serial Number REV2A2200046CN; \nSystem ID Number 11525316, UDI To be provided, Mfg. Lot/Serial Number REV2X2400082CN; \nSystem ID Number 11379817, UDI (01)00195278460271(11)240700(21)REV2X2400084CN, Mfg. Lot/Serial Number REV2X2400084CN; \nSystem ID Number 259056CT01, UDI (01)00195278460271(11)230800(21)REV2X2300051CN, Mfg. Lot/Serial Number REV2X2300051CN; \nSystem ID Number 11437190, UDI To be provided, Mfg. Lot/Serial Number CBGLG2400001HM; \nSystem ID Number 083021862540324, UDI (01)00195278460271(11)240800(21)REV2X2400101CN, Mfg. Lot/Serial Number REV2X2400101CN; \nSystem ID Number 7982CT0354, UDI (01)00195278460271(11)240200(21)REV2X2400011CN, Mfg. Lot/Serial Number REV2X2400011CN; \nSystem ID Number 7982CT0360, UDI (01)00195278460271(11)240100(21)REV2X2400005CN, Mfg. Lot/Serial Number REV2X2400005CN; \nSystem ID Number 13043139, UDI To be provided, Mfg. Lot/Serial Number Not Available; \nSystem ID Number A5624142, UDI To be provided, Mfg. Lot/Serial Number 00000440478CN6; \nSystem ID Number 11960464, UDI (01)00195278460271(11)240800(21)REV2X2400099CN, Mfg. Lot/Serial Number REV2X2400099CN; \nSystem ID Number 08876643, UDI (01)00195278460271(11)230700(21)REV2X2300037CN, Mfg. Lot/Serial Number REV2X2300037CN; \nSystem ID Number A5582819, UDI (01)00840682118552(11)170100(21)REVVX1700004CN, Mfg. Lot/Serial Number REVVX1700004CN; \nSystem ID Number 09897949, UDI (01)00195278460271(11)240700(21)REV2X2400092CN, Mfg. Lot/Serial Number REV2X2400092CN; \nSystem ID Number A5605766, UDI (01)00840682146319(11)240800(21)KITNH2400036CN, Mfg. Lot/Serial Number REVVX1900047CN; \nSystem ID Number REV075, UDI (01)00840682118552(11)190400(21)REVVX1900046CN, Mfg. Lot/Serial Number REVVX1900046CN; \nSystem ID Number CT00494, UDI (01)00195278460271(11)231000(21)REV2X2300070CN, Mfg. Lot/Serial Number REV2X2300070CN; \nSystem ID Number CT00468, UDI (01)00195278460271(11)240400(21)AEGGL2400005YC, Mfg. Lot/Serial Number AEGGL2400005YC; \nSystem ID Number CT00381, UDI (01)00195278460271(11)221100(21)REV2X2200003CN, Mfg. Lot/Serial Number REV2X2200003CN; \nSystem ID Number REV072, UDI (01)00840682118552(11)190400(21)REGGL1900004YC, Mfg. Lot/Serial Number REGGL1900004YC; \nSystem ID Number CT00488, UDI (01)00195278460271(11)231100(21)AEGGL2300002YC, Mfg. Lot/Serial Number AEGGL2300002YC; \nSystem ID Number CT00516, UDI (01)00195278460271(11)231200(21)AEGGL2300007YC, Mfg. Lot/Serial Number AEGGL2300007YC; \nSystem ID Number KRCT54358591, UDI To be provided, Mfg. Lot/Serial Number AEGGL2400010YC; \nSystem ID Number 0850211121, UDI (01)00195278460271(11)240600(21)REV2X2400066CN, Mfg. Lot/Serial Number REV2X2400066CN; \nSystem ID Number 0850211094, UDI (01)00195278460271(11)230800(21)REV2X2300048CN, Mfg. Lot/Serial Number REV2X2300048CN; \nSystem ID Number 0850210965, UDI (01)00840682123471(11)190600(21)REVV81900021CN, Mfg. Lot/Serial Number REVV81900021CN; \nSystem ID Number KW1018CT05, UDI (01)00840682118552(11)170300(21)REVVX1700034CN, Mfg. Lot/Serial Number REVVX1700034CN; \nSystem ID Number 859CT000190, UDI (01)00195278460271(11)230900(21)REV2X2300053CN, Mfg. Lot/Serial Number REV2X2300053CN; \nSystem ID Number NO1043CT05, UDI (01)00195278460271(11)240400(21)REV2X2300047CN, Mfg. Lot/Serial Number REV2X2300047CN; \nSystem ID Number NO1043CT04, UDI (01)00195278460271(11)240500(21)REV2X2400048CN, Mfg. Lot/Serial Number REV2X2400048CN; \nSystem ID Number 6073CT0095, UDI (01)00840682146616(11)230900(21)REV2A2300043CN, Mfg. Lot/Serial Number REV2A2300043CN; \nSystem ID Number P002CT03, UDI (01)00195278460271(11)230800(21)REV2X2300045CN, Mfg. Lot/Serial Number REV2X2300045CN; \nSystem ID Number L007CT02, UDI (01)00195278460271(11)231200(21)REV2X2300093CN, Mfg. Lot/Serial Number REV2X2300093CN; \nSystem ID Number R002CT10, UDI (01)00840682123471(11)180200(21)REVV81800003CN, Mfg. Lot/Serial Number REVV81800003CN; \nSystem ID Number O005CT14, UDI (01)00840682146616(11)200400(21)REV2A2000009CN, Mfg. Lot/Serial Number REV2A2000009CN; \nSystem ID Number 529150CT04, UDI (01)00195278460271(11)230600(21)REV2X2300019CN, Mfg. Lot/Serial Number REV2X2300019CN; \nSystem ID Number 529150CT02, UDI (01)00195278460271(11)230600(21)REV2X2300023CN, Mfg. Lot/Serial Number REV2X2300023CN; \nSystem ID Number 1573CT0126, UDI (01)00840682146616(11)220100(21)REV2A2200002CN, Mfg. Lot/Serial Number REV2A2200002CN; \nSystem ID Number THCTX24476143, UDI (01)00195278460271(11)241000(21)REV2X2400125CN, Mfg. Lot/Serial Number REV2X2400125CN; \nSystem ID Number 08124357, UDI (01)00840682146616(11)230400(21)REV2A2300024CN, Mfg. Lot/Serial Number REV2A2300024CN; \nSystem ID Number 09904040, UDI (01)00195278460271(11)240100(21)REV2X2400007CN, Mfg. Lot/Serial Number REV2X2400007CN; \nSystem ID Number 10231464, UDI To be provided, Mfg. Lot/Serial Number REV2X2500002CN", "firm_fei_number": "2126677", "recalling_firm": "GE Medical Systems, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "GE HealthCare Service\n800-437-1171", "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.", "root_cause_description": "Process change control", "action": "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: \n\"You can continue to use your system.\nPlease 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.\nPlease contact your local GE HealthCare service representative if any blue fluid is observed.\nPlease ensure all potential users in your facility are made aware of this safety notification and the recommended actions.\nPlease complete and return the attached acknowledgement form to recall.25504@gehealthcare.com.\"", "product_quantity": "105 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "k_number": [ "K882581", "K170273", "K203225", "K001682", "K181797", "K780480", "K780769", "K202213", "K936272", "K151283", "K183202", "K213649", "K990426", "K861698", "K230220", "K911387", "K253686", "K222819", "K760808", "K101888", "K133677", "K182716", "K213999", "K082816", "K151376", "K160587", "K161196", "K133646", "K211168", "K201586", "K863935", "K040372", "K043469", "K150785", "K261229", "K091934", "K063762", "K230162", "K223028", "K121553", "K131576", "K093581", "K943623", "K964583", "K761033", "K081022", "K151372", "K974455", "K081847", "K872150", "K791163", "K061449", "K212875", "K151752", "K072841", "K231574", "K013561", "K011447", "K193281", "K934832", "K193170", "K020929", "K970980", "K022326", "K173244", "K982536", "K974715", "K110066", "K880822", "K071378", "K843927", "K063324", "K033418", "K143294", "K151383", "K090504", "K213927", "K970819", "K193289", "K023760", "K102259", "K790134", "K982004", "K243523", "K110366", "K151919", "K191394", "K173625", "K214019", "K040902", "K102677", "K013521", "K212494", "K052216", "K253770", "K183161", "K251645", "K151749", "K073373", "K130224", "K003736", "K242403", "K802045", "K840860", "K093146", "K233731", "K211373", "K772317", "K232155", "K984156", "K220910", "K833228", "K770855", "K080624", "K213725", "K980837", "K133705", "K024149", "K191136", "K921192", "K102102", "K223447", "K142465", 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