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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

GE Revolution CT and Apex Series Systems Recalled for Coolant Leak Risk

Agency Publication Date: March 7, 2025
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Summary

GE HealthCare has initiated a voluntary recall of 479 gantry-based computed tomography (CT) systems, including several models within the Revolution CT and Revolution Apex series. The manufacturer identified a defect that allows blue coolant fluid (glycol) to leak onto the floor near the base of the gantry. While the glycol solution is not corrosive and is not at a harmful temperature, it creates a significant slip-and-fall hazard for hospital staff and patients if the leak is not noticed. No injuries have been specifically reported, but the potential for serious falls exists in a clinical environment.

Risk

The coolant fluid (glycol) used in the gantry cooling system can leak and accumulate on the floor. This creates a hidden or slippery surface near heavy medical machinery, which poses a risk of slips, trips, and falls for healthcare providers and patients transitioning onto or off the imaging table.

What You Should Do

  1. This recall affects various GE HealthCare computed tomography systems sold under the Revolution Apex (Elite, Expert, Plus, and Select) and Revolution CT (ES) series.
  2. Identify if your medical system is affected by checking the System ID Number, UDI, or Serial Number on the gantry or service records. See the Affected Products section below for the full list of affected codes.
  3. Check the floor area near the base of the gantry for any visible blue fluid, which indicates a coolant leak.
  4. Stop using the recalled device and secure the area to prevent slip-and-fall injuries.
  5. Contact GE HealthCare or your authorized medical equipment distributor to arrange for a formal inspection, return, replacement, or on-site correction of the cooling system.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: GE Healthcare Revolution Apex
Variants: System, X-ray, Tomography, Computed
Serial Numbers (53):
REV2X2300082CN
REVVX1900035CN
REV2X2400093CN
REV2X2300071CN
REV2X2400126CN
REV2X2300074CN
REVVX1700090CN
REVVX1600018CN
REV2X2400116CN
REV2X2400139CN
REV2X2400129CN
REV2A2100029CN
REV2X2400155CN
REV2X2400068CN
REV242200004CN
REV2X2400158CN
REV2X2300081CN
REV2X2400070CN
REV2X2400152CN
REV2X2400026CN
REV2X2300046CN
REVV82100041CN
REV2X2300075CN
REV2X2400167CN
00000441066CN8
REV2X2400055CN
REV2A2200006CN
REV2X2400053CN
REV2A2200007CN
REV2X2400024CN
REV2X2300026CN
REV2X2300087CN
CBFCG2400006HM
CBFCG2400004HM
REV2A2000001CN
REVV82100002CN
00000442412CN3
REV2X2300050CN
REVVX1600012CN
00000442334CN9
REV2X2300079CN
REV2X2300016CN
REVVX1700106CN
REV2X2400017CN
REV2A2100019CN
REV2X2400137CN
REV2X23000030CN
REV2X2400121CN
REV2X2400014CN
REVVX1800101CN
UDI:
00195278460271
00840682118552
00840682146616
00195278469700
00195278633149

System ID Numbers: 907729APEX1, 650493REV1, 630266CTRV, 773702REVCT6ED, 312996CTRV2, 1000000018, 617726Y6REV2, 617726Y6REV1, 336890APEX, 704801APEX, 336832APEX, 980993CT1, 910715REV1, 603650APEX1, 603526APEX, 973971REV161, 914787APEX, 718963EDCT, 315473APEX1, 614RMHAPEX1, 724357APEX, 843797REVCT2, 806775APEX, 703776APEX, 414805REVCT, 262577REVCT, 832CT000059, 833CT000155, AH7084CT02, AH1923CT01, BG4549CT04, E416249APEXCTE, 082421140968, 082421140960, 082421140959, DK1044CT12, DK1547CT01, DK1051CT04, CT52261701, M40230104, REV020, CT00486, KRCT54972221, KRCT54893311, 0850211084, NO1068CT04, P00652CT01, PL1672CT03, SA1420CT01, SA2973CT01, CT53972381, A201CT07, AC001CT05, 541010CT02, THCTX24524601, AE1025CT03

Product: GE Healthcare Revolution Apex Elite
Variants: System, X-ray, Tomography, Computed
Serial Numbers (243):
REV2X2300082CN
REV2X2300021CN
REV2X2400065CN
REV2X2400067CN
REV2X2300008CN
REV2X2400147CN
REV2X2300077CN
REV2X2300094CN
REV2X2400019CN
REV2X2400046CN
REV2X2400021CN
REV2X2400050CN
REV2X2400095CN
REV2X2400078CN
REV2X2400114CN
REV2X2400112CN
REV2X2300059CN
REV2X2400123CN
REV2X2300001CN
REV2X2300057CN
REV2X2300068CN
REV2X2300041CN
REV2X2400088CN
REV2X2400135CN
REV2X2400100CN
REV2X2400093CN
REV2X2300071CN
REV2X2400126CN
REV2X2300064CN
REV2X2300058CN
REV2X2300074CN
REV2X2400148CN
REV2X2400075CN
REV2X2400098CN
REV2X2300042CN
REV2X2300091CN
REV2X2300083CN
REV2X2400013CN
REV2X2300020CN
REV2X2400124CN
REV2X2400127CN
REV2X2300096CN
REV2X2300013CN
REV2X2300022CN
REV2X2400116CN
REV2X2400139CN
REV2X2400129CN
REV2X2400064CN
REV2X2400155CN
REV2X2400044CN
UDI:
00195278460271
00195278633149

Quantity: 250 units. Distributed Worldwide. System IDs include 907729APEX1, 256265STCT, 480342APEX1, 480342APEX3, 949250APEX, 858824REV, 707257APEX1, 714456APEX, 719227APEX1, 970945CT, 203576EDAPEX, 860224EDAPEX, 203276APEX1, 302744APEX, 561737APEX1, 561737APEX2, 786243APEX1, 305323APEX, 904UFNAPEX, 863680APEX, 786596APEX, 813972APEX, 813972APEX2, 813972APEX3, 770219APEX1, 630266CTRV, 773702REVCT6ED, 312996CTRV2, 708245APEX1, 309454APEX1, 1000000018, 1000005353, 815968CTRV, 317621APEX1, 913588APEX1, 913588APEX2, 270444APEXCT, 606451APEX1, 516252APEX, 508971REV, 412607CT1, 248898APEX1, 816271SJCT12, 314251APEX, 336890APEX, 704801APEX, 336832APEX, 336884APEX, 910715REV1, 402559REV6, 603650APEX1, 856886CTAPEX, 856355CTREV, 973971REV161, 973940APEX1, 973831APEX1, 973971APEX3, 505722APEX1, 575556REV1, 702961PCT, 702962RRCT, 718932APEX1, 914787APEX, 718963EDCT, 914737APEX, 631670APEX1, 516MHCTED1, HARLEMAPEXCT, 718226VZAPEX, 315473APEX1, 914681APEXCT1, 330729CTAPX2, 614RMHAPEX1, 614RMHAPEX2, 330841APEX1, 330480APEX1, 580559APEX160, 484526APEX, 717960CTAPEX, 717267CTREV, 724357APEX, 864512APEX1, 864725APEX2, 864560APEX1, 731541APX1, 512544APEX1, 512447APEX, 832325REV, 281477APEX1, 281477APEX3, 713R3ACT49, 713442REVEVO3, 713790APEX2, 713790APEX, 713R3ACT48, 414559REV1, 409772CT, 210757APEX, 806775APEX, 806775APEX1, 713790APEX1, 713442APEX, 713442REVEVO5, 385531CT2, 703504APEX, 434654CT, 703391APEX1, 703776APEX, 804594APEX1, 804267APEX1, 425688REV, 206223REV1, 608890APEXELITE, 262577REVCT, 832CT000234, AUCTX24429383, 832CT000230, AUCTX24566130, 833CT000211, AUCTX24493342, AUCTX24493214, AUCTX24491472, 833CT000155, AH4001CT06, AH1923CT01, 140024CT04, 220826CT05, 110094CT02, 441239APEX1, REV2X2400004CN, REV2X2400076CN, 12906848, BG4549CT04, 604557APEXRT1, 250635APEX, 5349227CT11, 867975APEX, 905522REVCT1, 905522REVCT2, E416249APEXCTE, E416249APEXCT2, E416249APEXCT1, 705522REVCT2, APEX160CMEXZ01, 12044778, DK1039CT02, DK1106CT02, DK1066CT01, DK1009CT01, CT52261701, FI1003CT14, 09974427, 12107537, 08089969, 11525316, 11379817, 259056CT01, HU1766CT01, 12743158, 083021862540324, 7982CT0354, 7982CT0360, 11960464, 08876643, 10025899, 08867431, 09897949, CT00442, CT00494, CT00495, CT00638, CT00468, CT00381, CT00611, CT00637, CT00488, CT00457, CT00516, CT00552, CT00460, CT00486, KRCT54358591, KRCT54358601, 0850211084, KRCT54933611, 0850211108, 0850211121, 0850211094, 110807CT06, 0828210145, LWD0320, LWD0324, 859CT000226, 859CT000190, NO1043CT05, NO1043CT04, 1557CT0318, P00652CT01, 600042CT07, PPR590118, SA2980CT01, SA2973CT01, CT53972381, SGCT54294581, 6073CT0103, SGCTX24467795, SGCTX24467793, 12622329, P002CT03, L007CT02, O009CT06, M007CT03, L001CT01, M001CT04, M001CT02, M004CT02, R002CT12, A201CT07, A201CT05, 222769CT01, 529150CT04, 529150CT02, 850030CT02, THCTX24524601, THCTX24513791, THCTX24476143, 12338981, 10127416, 09850616, 09993031, 10396521, 09904040, 10493318, 09526282, 10127401, 10131630, 10231464, 9830CT0444, VNCTX24476164, VNCT5320632A, VNCTX24515754.

Product: GE Healthcare Revolution Apex Expert
Variants: System, X-ray, Tomography, Computed
Serial Numbers:
REV2X2300082CN
REVV81800010CN
REV2X2300021CN
00000442592CN2
REV2A2200072CN
REV2X2400065CN
REV2X2400067CN
REVVX2000033CN
REV2X2300008CN
REVVX1600034CN
REV2X2400147CN
00000443327CN2
REVVX2100047CN
REV2X2300077CN
REV2X2300094CN
REVVX1900035CN
REVVX1900036CN
REV2A2200065CN
00000445059CN9
REV2X2400019CN
REV2X2400046CN
REV2X2400021CN
REV2X2400050CN
REV2X2400095CN
REV2X2400078CN
REV2X2400114CN
REV2X2400112CN
REV2X2300059CN
REV2X2400123CN
REV2X2300001CN
REV2X2300057CN
REV2X2300068CN
REVVX1800093CN
REV2X2300041CN
REV2X2400088CN
REV2X2400135CN
REV2X2400100CN
REVVX1900027CN
00000441716CN8
REV2X2400093CN
REV2X2300071CN
REV2X2400064CN
UDI:
00195278460271
00840682123471
00840682146616
00840682118552

Quantity: 42 units. System IDs include 907729APEX1, 205608CT, 256265STCT, 205699CTREV, 480342APEX, 480342APEX1, 480342APEX3, 11320, 949250APEX, 858657APEX, 858824REV, 858824APEX, 310423CT, 707257APEX1, 714456APEX, 650493REV1, 650493REV2, 818708CTWSO, 310222REVO, 719227APEX1, 970945CT, 203576EDAPEX, 860224EDAPEX, 203276APEX1, 302744APEX, 561737APEX1, 561737APEX2, 786243APEX1, 305323APEX, 904UFNAPEX, 863680APEX, 786596APEX, 786596REV, 813972APEX, 813972APEX2, 813972APEX3, 770219APEX1, 478633REVO, 808522RCT, 630266CTRV, 773702REVCT6ED, 336884APEX.

Product: GE Healthcare Revolution Apex Plus
Variants: System, X-ray, Tomography, Computed
Serial Numbers:
REV2X2300082CN
REV2X2400129CN
REVVX1600010CN
REV2A2300023CN
UDI:
00195278460271
00840682118552
00840682146616

Quantity: 4 units. System IDs: 907729APEX1, 336832APEX, 973971CTREV, 513584APEX1.

Product: GE Healthcare Revolution Apex Select
Variants: System, X-ray, Tomography, Computed
Serial Numbers:
REV2X2300082CN
UDI:
00195278460271

Quantity: 1 unit. System ID: 907729APEX1.

Product: GE Healthcare Revolution CT
Variants: System, X-ray, Tomography, Computed
Serial Numbers (104):
REV2X2300082CN
REV2A2200072CN
REV2X2400067CN
REV2X2300008CN
REVVX1600034CN
REVVX2100047CN
REV2X2300077CN
REVVX1900035CN
REVV81900011CN
REV2X2300001CN
REV2X2400088CN
REV2X2400135CN
00000441716CN8
REV2X2400126CN
REV2X2300064CN
REV2A2200050CN
REV282400043CN
REV2X2300091CN
REV2X2300083CN
REV2X2400124CN
REV2A2100036CN
REV2A2100029CN
REV2A2000015CN
REV2X2300063CN
REV242200002CN
REV2X2300090CN
REVVX1600013CN
REV2X2300009CN
REV2X2400113CN
REV2X2300040CN
REV2A2200119CN
REVVX1800108CN
REV2X2300060CN
REV2X2300049CN
REV2X2300036CN
REV2A2200105CN
REV2X2400132CN
REVV82200025CN
REVV82200045CN
REV2X2400081CN
00000443379CN3
REVVX1800047CN
REV2X2400055CN
REV2A2000010CN
CBGMG2400003HM
CBGMG2400004HM
REV2X2400053CN
REVVX1600011CN
REV2X2400024CN
REV2A2200013CN
UDI:
00195278460271
00840682146616
00840682118552
00195278502179
00840682146319
00840682123471

Quantity: 105 units. Distributed Worldwide. System IDs include 907729APEX1, 480342APEX, 480342APEX3, 949250APEX, 858657APEX, 310423CT, 707257APEX1, 650493REV1, 408559CTREVO, 904UFNAPEX, 813972APEX2, 813972APEX3, 808522RCT, 312996CTRV2, 708245APEX1, 718334CTREV, 765298APEX2, 913588APEX2, 270444APEXCT, 508971REV, 413794APCT, 980993CT1, 973971REV160, 702961PCT, 646962APEX1, 516MHCTED1, COR526548, 718226VZAPEX, 330480APEX1, 864725APEX2, 985NODCAPEX, 615936REVO, 713790APEX, 210757APEX, 713442APEX, 703776APEX1, 425688REV, 206320REV2, 206668REV, 608890APEXELITE, 608263REVCT, 414805IPCT, 262577REVCT, 83195527023, AUCTX24493214, AUCTX24491472, 833CT000155, 83155841562, AH1923CT01, 140024CT04, 030355CT07, 190059CT07, 030005CT04, 12906848, 250635APEX, 204726RCT, DK1547CT02, DK1106CT02, DK1009CT01, FI1003CT14, 06405034, C4193357, X143039508, 07272697, 11525316, 11379817, 259056CT01, 11437190, 083021862540324, 7982CT0354, 7982CT0360, 13043139, A5624142, 11960464, 08876643, A5582819, 09897949, A5605766, REV075, CT00494, CT00468, CT00381, REV072, CT00488, CT00516, KRCT54358591, 0850211121, 0850211094, 0850210965, KW1018CT05, 859CT000190, NO1043CT05, NO1043CT04, 6073CT0095, P002CT03, L007CT02, R002CT10, O005CT14, 529150CT04, 529150CT02, 1573CT0126, THCTX24476143, 08124357, 09904040, 10231464.

Product: GE Healthcare Revolution CT ES
Variants: System, X-ray, Tomography, Computed
Serial Numbers:
REV2X2300082CN
REVVX1900036CN
REV2X2400059CN
REV2X2400134CN
REVVX1900008CN
REVV82100006CN
00000441459CN5
REVV82200025CN
CBFCG2400026HM
REV2A2000001CN
REV2A2100002CN
REV2X2400082CN
REV2X2300051CN
CBGLG2400001HM
REV2X2300048CN
REV2X2400165CN
REV2X2300005CN
REVV81900003CN
REV2X2300012CN
REVVX1800101CN
UDI:
00195278460271
00195278633149
00840682146616
00840682123471
00840682118552

Quantity: 21 units. System IDs include 907729APEX1, 650493REV2, 864512APEX1, 832325REV, 281MWREVCT, 713792ACT39, 206320REV, 206320REV2, 082421190701, DK1044CT12, DK1547CT02, 11525316, 259056CT01, 11437190, 0850211094, 12622329, M001CT06, M004CT02, AC002CT05, R002CT12, AC001CT05.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96370
Status: Active
Manufacturer: GE Medical Systems, LLC
Sold By: Authorized medical equipment distributors; Direct sales to hospitals and clinics
Manufactured In: United States
Units Affected: 7 products (56 units; 250 units; 42 units; 4 units; 1 unit; 105 units; 21 units)
Distributed To: Nationwide

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. 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. Refer to the openFDA terms of service for more information.