Class IIOngoingZ-1302-2025
GE Medical Systems, LLC recalls GE Healthcare Revolution CT
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 CT, System, X-ray, Tomography, Computed
Lot / code information
- UDI
- (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/
- Serial #
- REV2X2300082CN; System ID Number 480342APEX
- UDI
- (01)00840682146616(11)220900(21)REV2A2200072CN, Mfg. Lot/
- Serial #
- REV2A2200072CN; 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 858657APEX
- UDI
- (01)00840682118552(11)160900(21)REVVX1600034CN, Mfg. Lot/
- Serial #
- REVVX1600034CN; System ID Number 310423CT
- UDI
- (01)00840682118552(11)211200(21)REVVX2100047CN, Mfg. Lot/
- Serial #
- REVVX2100047CN; System ID Number 707257APEX1
- UDI
- (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/
- Serial #
- REV2X2300077CN; System ID Number 650493REV1
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REVVX1900035CN; System ID Number 408559CTREVO
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REVV81900011CN; System ID Number 904UFNAPEX
- UDI
- (01)00195278460271(11)230300(21)REV2X2300001CN, Mfg. Lot/
- Serial #
- REV2X2300001CN; 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 808522RCT
- UDI
- t Applicable, Mfg. Lot/
- Serial #
- 00000441716CN8; 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 718334CTREV
- UDI
- (01)00840682146616(11)220700(21)REV2A2200050CN, Mfg. Lot/
- Serial #
- REV2A2200050CN; System ID Number 765298APEX2
- UDI
- (01)00195278502179(11)241000(21)REV282400043CN, Mfg. Lot/
- Serial #
- REV282400043CN; 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 508971REV
- UDI
- (01)00195278460271(11)241000(21)REV2X2400124CN, Mfg. Lot/
- Serial #
- REV2X2400124CN; System ID Number 413794APCT
- UDI
- (01)00840682146616(11)210800(21)REV2A2100036CN, Mfg. Lot/
- Serial #
- REV2A2100036CN; System ID Number 980993CT1
- UDI
- (01)00840682146616(11)210700(21)REV2A2100029CN, Mfg. Lot/
- Serial #
- REV2A2100029CN; System ID Number 973971REV160
- UDI
- (01)00840682146616(11)200600(21)REV2A2000015CN, Mfg. Lot/
- Serial #
- REV2A2000015CN; System ID Number 702961PCT
- UDI
- (01)00195278460271(11)230900(21)REV2X2300063CN, Mfg. Lot/
- Serial #
- REV2X2300063CN; System ID Number 646962APEX1
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV242200002CN; System ID Number 516MHCTED1
- UDI
- (01)00195278460271(11)231200(21)REV2X2300090CN, Mfg. Lot/
- Serial #
- REV2X2300090CN; System ID Number COR526548
- UDI
- (01)00840682118552(11)160700(21)REVVX1600013CN, Mfg. Lot/
- Serial #
- REVVX1600013CN; System ID Number 718226VZAPEX
- UDI
- (01)00195278460271(11)230500(21)REV2X2300009CN, Mfg. Lot/
- Serial #
- REV2X2300009CN; System ID Number 330480APEX1
- UDI
- (01)00195278460271(11)240900(21)REV2X2400113CN, Mfg. Lot/
- Serial #
- REV2X2400113CN; System ID Number 864725APEX2
- UDI
- (01)00195278460271(11)230700(21)REV2X2300040CN, Mfg. Lot/
- Serial #
- REV2X2300040CN; System ID Number 985NODCAPEX
- UDI
- (01)00840682146616(11)221200(21)REV2A2200119CN, Mfg. Lot/
- Serial #
- REV2A2200119CN; System ID Number 615936REVO
- UDI
- (01)00840682118552(11)181000(21)REVVX1800108CN, Mfg. Lot/
- Serial #
- REVVX1800108CN; System ID Number 713790APEX
- UDI
- (01)00195278460271(11)230900(21)REV2X2300060CN, Mfg. Lot/
- Serial #
- REV2X2300060CN; System ID Number 210757APEX
- UDI
- (01)00195278460271(11)230800(21)REV2X2300049CN, Mfg. Lot/
- Serial #
- REV2X2300049CN; System ID Number 713442APEX
- UDI
- (01)00195278460271(11)230700(21)REV2X2300036CN, Mfg. Lot/
- Serial #
- REV2X2300036CN; System ID Number 703776APEX1
- UDI
- (01)00840682146616(11)221100(21)REV2A2200105CN, Mfg. Lot/
- Serial #
- REV2A2200105CN; System ID Number 425688REV
- UDI
- (01)00195278460271(11)241000(21)REV2X2400132CN, Mfg. Lot/
- Serial #
- REV2X2400132CN; System ID Number 206320REV2
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REVV82200025CN; System ID Number 206668REV
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REVV82200045CN; System ID Number 608890APEXELITE
- UDI
- (01)00195278460271(11)240700(21)REV2X2400081CN, Mfg. Lot/
- Serial #
- REV2X2400081CN; System ID Number 608263REVCT
- UDI
- t Applicable, Mfg. Lot/
- Serial #
- 00000443379CN3; System ID Number 414805IPCT
- UDI
- (01)00840682118552(11)180500(21)REVVX1800047CN, Mfg. Lot/
- Serial #
- REVVX1800047CN; System ID Number 262577REVCT
- UDI
- (01)00195278460271(11)240500(21)REV2X2400055CN, Mfg. Lot/
- Serial #
- REV2X2400055CN; System ID Number 83195527023
- UDI
- (01)00840682146616(11)200400(21)REV2A2000010CN, Mfg. Lot/
- Serial #
- REV2A2000010CN; 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 83155841562
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REVVX1600011CN; 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 030355CT07
- UDI
- To be provided, Mfg. Lot/
- Serial #
- 441578CN2; System ID Number 190059CT07
- UDI
- (01)00840682146616(11)211200(21)REV2A2100053CN, Mfg. Lot/
- Serial #
- REV2A2100053CN; System ID Number 030005CT04
- UDI
- (01)00840682118552(11)211100(21)REVVX2100043CN, Mfg. Lot/
- Serial #
- REVVX2100043CN; System ID Number 12906848
- UDI
- (01)00195278460271(11)241100(21)REV2X2400140CN, Mfg. Lot/
- Serial #
- REV2X2400140CN; System ID Number 250635APEX
- UDI
- (01)00195278460271(11)240400(21)REV2X2400045CN, Mfg. Lot/
- Serial #
- REV2X2400045CN; System ID Number 204726RCT
- UDI
- (01)00840682146616(11)200600(21)REV2A2000017CN, Mfg. Lot/
- Serial #
- REV2A2000017CN; System ID Number DK1547CT02
- UDI
- (01)00840682146616(11)210100(21)REV2A2100002CN, Mfg. Lot/
- Serial #
- REV2A2100002CN; System ID Number DK1106CT02
- UDI
- (01)00195278460271(11)230900(21)REV2X2300055CN, Mfg. Lot/
- Serial #
- REV2X2300055CN; System ID Number DK1009CT01
- UDI
- (01)00195278460271(11)221200(21)REV2X2200002CN, Mfg. Lot/
- Serial #
- REV2X2200002CN; System ID Number FI1003CT14
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400164CN; System ID Number 06405034
- UDI
- (01)00840682146616(11)220500(21)REV2A2200029CN, Mfg. Lot/
- Serial #
- REV2A2200029CN; System ID Number C4193357
- UDI
- (01)00840682146616(11)210800(21)REV2A2100033CN, Mfg. Lot/
- Serial #
- REV2A2100033CN; System ID Number X143039508
- UDI
- (01)00840682118552(11)170700(21)REVVX1700074CN, Mfg. Lot/
- Serial #
- REVVX1700074CN; System ID Number 07272697
- UDI
- (01)00840682146616(11)220600(21)REV2A2200046CN, Mfg. Lot/
- Serial #
- REV2A2200046CN; 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 11437190
- UDI
- To be provided, Mfg. Lot/
- Serial #
- CBGLG2400001HM; 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 13043139
- UDI
- To be provided, Mfg. Lot/
- Serial #
- t Available; System ID Number A5624142
- UDI
- To be provided, Mfg. Lot/
- Serial #
- 00000440478CN6; 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 A5582819
- UDI
- (01)00840682118552(11)170100(21)REVVX1700004CN, Mfg. Lot/
- Serial #
- REVVX1700004CN; System ID Number 09897949
- UDI
- (01)00195278460271(11)240700(21)REV2X2400092CN, Mfg. Lot/
- Serial #
- REV2X2400092CN; System ID Number A5605766
- UDI
- (01)00840682146319(11)240800(21)KITNH2400036CN, Mfg. Lot/
- Serial #
- REVVX1900047CN; System ID Number REV075
- UDI
- (01)00840682118552(11)190400(21)REVVX1900046CN, Mfg. Lot/
- Serial #
- REVVX1900046CN; System ID Number CT00494
- UDI
- (01)00195278460271(11)231000(21)REV2X2300070CN, Mfg. Lot/
- Serial #
- REV2X2300070CN; 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 REV072
- UDI
- (01)00840682118552(11)190400(21)REGGL1900004YC, Mfg. Lot/
- Serial #
- REGGL1900004YC; System ID Number CT00488
- UDI
- (01)00195278460271(11)231100(21)AEGGL2300002YC, Mfg. Lot/
- Serial #
- AEGGL2300002YC; System ID Number CT00516
- UDI
- (01)00195278460271(11)231200(21)AEGGL2300007YC, Mfg. Lot/
- Serial #
- AEGGL2300007YC; System ID Number KRCT54358591
- UDI
- To be provided, Mfg. Lot/
- Serial #
- AEGGL2400010YC; 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 0850210965
- UDI
- (01)00840682123471(11)190600(21)REVV81900021CN, Mfg. Lot/
- Serial #
- REVV81900021CN; System ID Number KW1018CT05
- UDI
- (01)00840682118552(11)170300(21)REVVX1700034CN, Mfg. Lot/
- Serial #
- REVVX1700034CN; 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 6073CT0095
- UDI
- (01)00840682146616(11)230900(21)REV2A2300043CN, Mfg. Lot/
- Serial #
- REV2A2300043CN; 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 R002CT10
- UDI
- (01)00840682123471(11)180200(21)REVV81800003CN, Mfg. Lot/
- Serial #
- REVV81800003CN; System ID Number O005CT14
- UDI
- (01)00840682146616(11)200400(21)REV2A2000009CN, Mfg. Lot/
- Serial #
- REV2A2000009CN; 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 1573CT0126
- UDI
- (01)00840682146616(11)220100(21)REV2A2200002CN, Mfg. Lot/
- Serial #
- REV2A2200002CN; System ID Number THCTX24476143
- UDI
- (01)00195278460271(11)241000(21)REV2X2400125CN, Mfg. Lot/
- Serial #
- REV2X2400125CN; System ID Number 08124357
- UDI
- (01)00840682146616(11)230400(21)REV2A2300024CN, Mfg. Lot/
- Serial #
- REV2A2300024CN; System ID Number 09904040
- UDI
- (01)00195278460271(11)240100(21)REV2X2400007CN, Mfg. Lot/
- Serial #
- REV2X2400007CN; System ID Number 10231464
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2500002CN
Show 200 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-1302-2025
- 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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