GE Medical Systems, LLC recalls GE Healthcare Revolution Apex
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, System, X-ray, Tomography, Computed
Lot / code information
- UDI
- (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/
- Serial #
- REV2X2300082CN; System ID Number: 650493REV1
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REVVX1900035CN; 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: 1000000018
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2300074CN; System ID Number: 617726Y6REV2
- UDI
- (01)00840682118552(11)170900(21)REVVX1700090CN, Mfg. Lot/
- Serial #
- REVVX1700090CN; System ID Number: 617726Y6REV1
- UDI
- (01)00840682118552(11)160700(21)REVVX1600018CN, Mfg. Lot/
- Serial #
- REVVX1600018CN; 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: 980993CT1
- UDI
- (01)00840682146616(11)210700(21)REV2A2100029CN, Mfg. Lot/
- Serial #
- REV2A2100029CN; System ID Number: 910715REV1
- UDI
- (01)00195278460271(11)241200(21)REV2X2400155CN, Mfg. Lot/
- Serial #
- REV2X2400155CN; System ID Number: 603650APEX1
- UDI
- (01)00195278460271(11)240600(21)REV2X2400068CN, Mfg. Lot/
- Serial #
- REV2X2400068CN; System ID Number: 603526APEX
- UDI
- (01)00195278469700(11)230100(21)REV242200004CN, Mfg. Lot/
- Serial #
- REV242200004CN; System ID Number: 973971REV161
- UDI
- (01)00195278460271(11)241200(21)REV2X2400158CN, Mfg. Lot/
- Serial #
- REV2X2400158CN; 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: 315473APEX1
- UDI
- (01)00195278460271(11)241100(21)REV2X2400152CN, Mfg. Lot/
- Serial #
- REV2X2400152CN; System ID Number: 614RMHAPEX1
- UDI
- (01)00195278460271(11)240300(21)REV2X2400026CN, Mfg. Lot/
- Serial #
- REV2X2400026CN; System ID Number: 724357APEX
- UDI
- (01)00195278460271(11)230800(21)REV2X2300046CN, Mfg. Lot/
- Serial #
- REV2X2300046CN; System ID Number: 843797REVCT2
- UDI
- (01)00840682123471(11)211100(21)REVV82100041CN, Mfg. Lot/
- Serial #
- REVV82100041CN; System ID Number: 806775APEX
- UDI
- (01)00195278460271(11)231000(21)REV2X2300075CN, Mfg. Lot/
- Serial #
- REV2X2300075CN; System ID Number: 703776APEX
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400167CN; System ID Number: 414805REVCT
- UDI
- t Applicable, Mfg. Lot/
- Serial #
- 00000441066CN8; System ID Number: 262577REVCT
- UDI
- (01)00195278460271(11)240500(21)REV2X2400055CN, Mfg. Lot/
- Serial #
- REV2X2400055CN; System ID Number: 832CT000059
- UDI
- (01)00840682146616(11)220100(21)REV2A2200006CN, Mfg. Lot/
- Serial #
- REV2A2200006CN; System ID Number: 833CT000155
- UDI
- (01)00195278460271(11)240500(21)REV2X2400053CN, Mfg. Lot/
- Serial #
- REV2X2400053CN; System ID Number: AH7084CT02
- UDI
- (01)00840682146616(11)220100(21)REV2A2200007CN, Mfg. Lot/
- Serial #
- REV2A2200007CN; System ID Number: AH1923CT01
- UDI
- (01)00195278460271(11)240300(21)REV2X2400024CN, Mfg. Lot/
- Serial #
- REV2X2400024CN; System ID Number: BG4549CT04
- UDI
- (01)00195278460271(11)230600(21)REV2X2300026CN, Mfg. Lot/
- Serial #
- REV2X2300026CN; System ID Number: E416249APEXCTE
- UDI
- (01)00195278460271(11)231100(21)REV2X2300087CN, Mfg. Lot/
- Serial #
- REV2X2300087CN; System ID Number: 082421140968
- UDI
- To be provided, Mfg. Lot/
- Serial #
- t Available; System ID Number: 082421140960
- UDI
- (01)00195278633149(11)240500(21)CBFCG2400006HM, Mfg. Lot/
- Serial #
- CBFCG2400006HM; System ID Number: 082421140959
- UDI
- (01)00195278633149(11)240500(21)CBFCG2400004HM, Mfg. Lot/
- Serial #
- CBFCG2400004HM; System ID Number: DK1044CT12
- UDI
- (01)00840682146616(11)200200(21)REV2A2000001CN, Mfg. Lot/
- Serial #
- REV2A2000001CN; System ID Number: DK1547CT01
- UDI
- (01)00840682123471(11)210100(21)REVV82100002CN, Mfg. Lot/
- Serial #
- REVV82100002CN; System ID Number: DK1051CT04
- UDI
- To be provided, Mfg. Lot/
- Serial #
- 00000442412CN3; System ID Number: CT52261701
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2300050CN; System ID Number: M40230104
- UDI
- (01)00840682118552(11)160600(21)REVVX1600012CN, Mfg. Lot/
- Serial #
- REVVX1600012CN; System ID Number: REV020
- UDI
- To be provided, Mfg. Lot/
- Serial #
- 00000442334CN9; 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: 0850211084
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2300016CN; System ID Number: NO1068CT04
- UDI
- (01)00840682118552(11)171000(21)REVVX1700106CN, Mfg. Lot/
- Serial #
- REVVX1700106CN; System ID Number: P00652CT01
- UDI
- (01)00195278460271(11)240200(21)REV2X2400017CN, Mfg. Lot/
- Serial #
- REV2X2400017CN; System ID Number: PL1672CT03
- UDI
- (01)00840682146616(11)210600(21)REV2A2100019CN, Mfg. Lot/
- Serial #
- REV2A2100019CN; System ID Number: SA1420CT01
- UDI
- To be provided, Mfg. Lot/
- Serial #
- REV2X2400137CN; 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: A201CT07
- UDI
- (01)00195278460271(11)240200(21)REV2X2400014CN, Mfg. Lot/
- Serial #
- REV2X2400014CN; System ID Number: AC001CT05
- UDI
- (01)00840682118552(11)181000(21)REVVX1800101CN, Mfg. Lot/
- Serial #
- REVVX1800101CN; System ID Number: 541010CT02
- UDI
- (01)00840682118552(11)190900(21)REVVX1900106CN, Mfg. Lot/
- Serial #
- REVVX1900106CN; System ID Number: THCTX24524601
- UDI
- (01)00195278460271(11)241000(21)REV2X2400131CN, Mfg. Lot/
- Serial #
- REV2X2400131CN; System ID Number: AE1025CT03
- UDI
- (01)00840682118552(11)210300(21)REVVX2100010CN, Mfg. Lot/
- Serial #
- REVVX2100010CN
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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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1297-2025
- FDA 510(k) clearance · K163213The device's official FDA premarket clearance record
- FDA 510(k) clearance · K191777The device's official FDA premarket clearance record
- 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 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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