GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE Medical Systems, LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1299-2025
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