CLASS II ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report
GE Healthcare Revolution Apex Expert, System, X-ray recalled
GE Medical Systems is recalling GE Healthcare Revolution Apex Expert, 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-1299-2025
- 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 Expert, 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 205608CT, UDI (01)00840682123471(11)180800(21)REVV81800010CN, Mfg. Lot/Serial Number REVV81800010CN; System ID Number 256265STCT, UDI (01)00195278460271(11)230600(21)REV2X2300021CN, Mfg. Lot/Serial Number REV2X2300021CN; System ID Number 205699CTREV, UDI Not Applicable, Mfg. Lot/Serial Number 00000442592CN2; System ID Number 480342APEX, UDI (01)00840682146616(11)220900(21)REV2A2200072CN, Mfg. Lot/Serial Number REV2A2200072CN; System ID Number 480342APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400065CN, Mfg. Lot/Serial Number REV2X2400065CN; System ID Number 480342APEX3, UDI (01)00195278460271(11)240600(21)REV2X2400067CN, Mfg. Lot/Serial Number REV2X2400067CN; System ID Number 11320, UDI To be provided, Mfg. Lot/Serial Number REVVX2000033CN; System ID Number 949250APEX, UDI (01)00195278460271(11)230500(21)REV2X2300008CN, Mfg. Lot/Serial Number REV2X2300008CN; System ID Number 858657APEX, UDI (01)00840682118552(11)160900(21)REVVX1600034CN, Mfg. Lot/Serial Number REVVX1600034CN; System ID Number 858824REV, UDI (01)00195278460271(11)241100(21)REV2X2400147CN, Mfg. Lot/Serial Number REV2X2400147CN; System ID Number 858824APEX, UDI Not Applicable, Mfg. Lot/Serial Number 00000443327CN2; System ID Number 310423CT, UDI (01)00840682118552(11)211200(21)REVVX2100047CN, Mfg. Lot/Serial Number REVVX2100047CN; System ID Number 707257APEX1, UDI (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/Serial Number REV2X2300077CN; System ID Number 714456APEX, UDI (01)00195278460271(11)231200(21)REV2X2300094CN, Mfg. Lot/Serial Number REV2X2300094CN; System ID Number 650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN; System ID Number 650493REV2, UDI To be provided, Mfg. Lot/Serial Number REVVX1900036CN; System ID Number 818708CTWSO, UDI (01)00840682146616(11)220900(21)REV2A2200065CN, Mfg. Lot/Serial Number REV2A2200065CN; System ID Number 310222REVO, UDI Not Applicable, Mfg. Lot/Serial Number 00000445059CN9; System ID Number 719227APEX1, UDI (01)00195278460271(11)240200(21)REV2X2400019CN, Mfg. Lot/Serial Number REV2X2400019CN; System ID Number 970945CT, UDI (01)00195278460271(11)240400(21)REV2X2400046CN, Mfg. Lot/Serial Number REV2X2400046CN; System ID Number 203576EDAPEX, UDI (01)00195278460271(11)240300(21)REV2X2400021CN, Mfg. Lot/Serial Number REV2X2400021CN; System ID Number 860224EDAPEX, UDI (01)00195278460271(11)240500(21)REV2X2400050CN, Mfg. Lot/Serial Number REV2X2400050CN; System ID Number 203276APEX1, UDI (01)00195278460271(11)240800(21)REV2X2400095CN, Mfg. Lot/Serial Number REV2X2400095CN; System ID Number 302744APEX, UDI (01)00195278460271(11)240600(21)REV2X2400078CN, Mfg. Lot/Serial Number REV2X2400078CN; System ID Number 561737APEX1, UDI (01)00195278460271(11)240900(21)REV2X2400114CN, Mfg. Lot/Serial Number REV2X2400114CN; System ID Number 561737APEX2, UDI (01)00195278460271(11)240900(21)REV2X2400112CN, Mfg. Lot/Serial Number REV2X2400112CN; System ID Number 786243APEX1, UDI (01)00195278460271(11)230900(21)REV2X2300059CN, Mfg. Lot/Serial Number REV2X2300059CN; System ID Number 305323APEX, UDI (01)00195278460271(11)240900(21)REV2X2400123CN, Mfg. Lot/Serial Number REV2X2400123CN; System ID Number 904UFNAPEX, UDI (01)00195278460271(11)230300(21)REV2X2300001CN, Mfg. Lot/Serial Number REV2X2300001CN; System ID Number 863680APEX, UDI (01)00195278460271(11)230900(21)REV2X2300057CN, Mfg. Lot/Serial Number REV2X2300057CN; System ID Number 786596APEX, UDI (01)00195278460271(11)230900(21)REV2X2300068CN, Mfg. Lot/Serial Number REV2X2300068CN; System ID Number 786596REV, UDI (01)00840682118552(11)180900(21)REVVX1800093CN, Mfg. Lot/Serial Number REVVX1800093CN; System ID Number 813972APEX, UDI (01)00195278460271(11)230800(21)REV2X2300041CN, Mfg. Lot/Serial Number REV2X2300041CN; System ID Number 813972APEX2, UDI (01)00195278460271(11)240700(21)REV2X2400088CN, Mfg. Lot/Serial Number REV2X2400088CN; System ID Number 813972APEX3, UDI (01)00195278460271(11)241000(21)REV2X2400135CN, Mfg. Lot/Serial Number REV2X2400135CN; System ID Number 770219APEX1, UDI (01)00195278460271(11)240800(21)REV2X2400100CN, Mfg. Lot/Serial Number REV2X2400100CN; System ID Number 478633REVO, UDI (01)00840682118552(11)190200(21)REVVX1900027CN, Mfg. Lot/Serial Number REVVX1900027CN; System ID Number 808522RCT, UDI Not Applicable, Mfg. Lot/Serial Number 00000441716CN8; 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 336884APEX, UDI (01)00195278460271(11)240500(21)REV2X2400064CN, Mfg. Lot/Serial Number REV2X2400064CN
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 96370This product is part of a recall event; the main page for the event is GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed recalled.
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