CLASS II ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed recalled
GE Medical Systems is recalling GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed. The recall was initiated on 18 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1297-2025
- FDA event ID
- 96370
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Feb 2025
- FDA classified
- 7 Mar 2025
- Reported
- 19 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Imaging Equipment
Timeline
| 18 Feb 2025 | Recall initiated by company | |
| 7 Mar 2025 | Classified by FDA | +17 days |
| 19 Mar 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
System ID Number: 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number: 650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN; System ID Number: 630266CTRV, UDI (01)00195278460271(11)240800(21)REV2X2400093CN, Mfg. Lot/Serial Number REV2X2400093CN; System ID Number: 773702REVCT6ED, UDI (01)00195278460271(11)231000(21)REV2X2300071CN, Mfg. Lot/Serial Number REV2X2300071CN; System ID Number: 312996CTRV2, UDI (01)00195278460271(11)241000(21)REV2X2400126CN, Mfg. Lot/Serial Number REV2X2400126CN; System ID Number: 1000000018, UDI To be provided, Mfg. Lot/Serial Number REV2X2300074CN; System ID Number: 617726Y6REV2, UDI (01)00840682118552(11)170900(21)REVVX1700090CN, Mfg. Lot/Serial Number REVVX1700090CN; System ID Number: 617726Y6REV1, UDI (01)00840682118552(11)160700(21)REVVX1600018CN, Mfg. Lot/Serial Number REVVX1600018CN; System ID Number: 336890APEX, UDI (01)00195278460271(11)240900(21)REV2X2400116CN, Mfg. Lot/Serial Number REV2X2400116CN; System ID Number: 704801APEX, UDI (01)00195278460271(11)241000(21)REV2X2400139CN, Mfg. Lot/Serial Number REV2X2400139CN; System ID Number: 336832APEX, UDI (01)00195278460271(11)241000(21)REV2X2400129CN, Mfg. Lot/Serial Number REV2X2400129CN; System ID Number: 980993CT1, UDI (01)00840682146616(11)210700(21)REV2A2100029CN, Mfg. Lot/Serial Number REV2A2100029CN; System ID Number: 910715REV1, UDI (01)00195278460271(11)241200(21)REV2X2400155CN, Mfg. Lot/Serial Number REV2X2400155CN; System ID Number: 603650APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400068CN, Mfg. Lot/Serial Number REV2X2400068CN; System ID Number: 603526APEX, UDI (01)00195278469700(11)230100(21)REV242200004CN, Mfg. Lot/Serial Number REV242200004CN; System ID Number: 973971REV161, UDI (01)00195278460271(11)241200(21)REV2X2400158CN, Mfg. Lot/Serial Number REV2X2400158CN; System ID Number: 914787APEX, UDI (01)00195278460271(11)231000(21)REV2X2300081CN, Mfg. Lot/Serial Number REV2X2300081CN; System ID Number: 718963EDCT, UDI (01)00195278460271(11)240600(21)REV2X2400070CN, Mfg. Lot/Serial Number REV2X2400070CN; System ID Number: 315473APEX1, UDI (01)00195278460271(11)241100(21)REV2X2400152CN, Mfg. Lot/Serial Number REV2X2400152CN; System ID Number: 614RMHAPEX1, UDI (01)00195278460271(11)240300(21)REV2X2400026CN, Mfg. Lot/Serial Number REV2X2400026CN; System ID Number: 724357APEX, UDI (01)00195278460271(11)230800(21)REV2X2300046CN, Mfg. Lot/Serial Number REV2X2300046CN; System ID Number: 843797REVCT2, UDI (01)00840682123471(11)211100(21)REVV82100041CN, Mfg. Lot/Serial Number REVV82100041CN; System ID Number: 806775APEX, UDI (01)00195278460271(11)231000(21)REV2X2300075CN, Mfg. Lot/Serial Number REV2X2300075CN; System ID Number: 703776APEX, UDI To be provided, Mfg. Lot/Serial Number REV2X2400167CN; System ID Number: 414805REVCT, UDI Not Applicable, Mfg. Lot/Serial Number 00000441066CN8; System ID Number: 262577REVCT, UDI (01)00195278460271(11)240500(21)REV2X2400055CN, Mfg. Lot/Serial Number REV2X2400055CN; System ID Number: 832CT000059, UDI (01)00840682146616(11)220100(21)REV2A2200006CN, Mfg. Lot/Serial Number REV2A2200006CN; System ID Number: 833CT000155, UDI (01)00195278460271(11)240500(21)REV2X2400053CN, Mfg. Lot/Serial Number REV2X2400053CN; System ID Number: AH7084CT02, UDI (01)00840682146616(11)220100(21)REV2A2200007CN, Mfg. Lot/Serial Number REV2A2200007CN; System ID Number: AH1923CT01, UDI (01)00195278460271(11)240300(21)REV2X2400024CN, Mfg. Lot/Serial Number REV2X2400024CN; System ID Number: BG4549CT04, UDI (01)00195278460271(11)230600(21)REV2X2300026CN, Mfg. Lot/Serial Number REV2X2300026CN; System ID Number: E416249APEXCTE, UDI (01)00195278460271(11)231100(21)REV2X2300087CN, Mfg. Lot/Serial Number REV2X2300087CN; System ID Number: 082421140968, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number: 082421140960, UDI (01)00195278633149(11)240500(21)CBFCG2400006HM, Mfg. Lot/Serial Number CBFCG2400006HM; System ID Number: 082421140959, UDI (01)00195278633149(11)240500(21)CBFCG2400004HM, Mfg. Lot/Serial Number CBFCG2400004HM; System ID Number: DK1044CT12, UDI (01)00840682146616(11)200200(21)REV2A2000001CN, Mfg. Lot/Serial Number REV2A2000001CN; System ID Number: DK1547CT01, UDI (01)00840682123471(11)210100(21)REVV82100002CN, Mfg. Lot/Serial Number REVV82100002CN; System ID Number: DK1051CT04, UDI To be provided, Mfg. Lot/Serial Number 00000442412CN3; System ID Number: CT52261701, UDI To be provided, Mfg. Lot/Serial Number REV2X2300050CN; System ID Number: M40230104, UDI (01)00840682118552(11)160600(21)REVVX1600012CN, Mfg. Lot/Serial Number REVVX1600012CN; System ID Number: REV020, UDI To be provided, Mfg. Lot/Serial Number 00000442334CN9; System ID Number: CT00486, UDI (01)00195278460271(11)231000(21)REV2X2300079CN, Mfg. Lot/Serial Number REV2X2300079CN; System ID Number: KRCT54972221, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number: KRCT54893311, UDI To be provided, Mfg. Lot/Serial Number Not Available; System ID Number: 0850211084, UDI To be provided, Mfg. Lot/Serial Number REV2X2300016CN; System ID Number: NO1068CT04, UDI (01)00840682118552(11)171000(21)REVVX1700106CN, Mfg. Lot/Serial Number REVVX1700106CN; System ID Number: P00652CT01, UDI (01)00195278460271(11)240200(21)REV2X2400017CN, Mfg. Lot/Serial Number REV2X2400017CN; System ID Number: PL1672CT03, UDI (01)00840682146616(11)210600(21)REV2A2100019CN, Mfg. Lot/Serial Number REV2A2100019CN; System ID Number: SA1420CT01, UDI To be provided, Mfg. Lot/Serial Number REV2X2400137CN; System ID Number: SA2973CT01, UDI To be provided, Mfg. Lot/Serial Number REV2X23000030CN; System ID Number: CT53972381, UDI To be provided, Mfg. Lot/Serial Number REV2X2400121CN; System ID Number: A201CT07, UDI (01)00195278460271(11)240200(21)REV2X2400014CN, Mfg. Lot/Serial Number REV2X2400014CN; System ID Number: AC001CT05, UDI (01)00840682118552(11)181000(21)REVVX1800101CN, Mfg. Lot/Serial Number REVVX1800101CN; System ID Number: 541010CT02, UDI (01)00840682118552(11)190900(21)REVVX1900106CN, Mfg. Lot/Serial Number REVVX1900106CN; System ID Number: THCTX24524601, UDI (01)00195278460271(11)241000(21)REV2X2400131CN, Mfg. Lot/Serial Number REV2X2400131CN; System ID Number: AE1025CT03, UDI (01)00840682118552(11)210300(21)REVVX2100010CN, Mfg. Lot/Serial Number REVVX2100010CN.
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 96370More recalls from GE Medical Systems
All 160| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Optima XR240amx, Mobile Digital Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Optima XR220amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Optima XR200amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Giraffe OmniBed Field Replaceable Unit (FRU) recalled | GE Medical Systems | Other | Nationwide |
| Device | CLASS II | Allia IGS 7 Pulse angiographic X-ray system recalled | GE Medical Systems | Other | Nationwide |
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