The Recall Desk
HighFDA (Devices)·Z-1298-2025·Announced 2025-03-19

GE Revolution CT and Apex systems coolant fluid leak hazard

GE Healthcare Revolution CT and Apex series imaging systems may leak blue coolant fluid near the gantry base, creating a potential slip and fall hazard. Approximately 250 units have been distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall for a risk-of-harm product (slip and fall hazard from leaked coolant) where no injuries have been reported, fitting the rubric criterion for score 3.

Plain-English summary

GE Healthcare has identified a potential issue affecting Revolution CT and Revolution Apex series computed tomography (CT) imaging systems. Certain units may leak coolant fluid (glycol) onto the floor near the base of the gantry.

The coolant is blue in color and 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.

Approximately 250 units have been identified as affected, with worldwide distribution. The recall was issued by GE Medical Systems, LLC, and identified by the FDA under recall number Z-1298-2025.

The recalled product

Product
GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Medical Imaging
Hazard
  • slip-fall
  • coolant-leak

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • System ID Number 907729APEX1
  • UDI (01)00195278460271(11)231100(21)REV2X2300082CN
  • Mfg. Lot/Serial Number REV2X2300082CN
  • System ID Number 256265STCT
  • UDI (01)00195278460271(11)230600(21)REV2X2300021CN
  • Mfg. Lot/Serial Number REV2X2300021CN
  • 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 949250APEX
  • UDI (01)00195278460271(11)230500(21)REV2X2300008CN
  • Mfg. Lot/Serial Number REV2X2300008CN
  • System ID Number 858824REV
  • UDI (01)00195278460271(11)241100(21)REV2X2400147CN
  • Mfg. Lot/Serial Number REV2X2400147CN
  • System ID Number 707257APEX1
  • UDI (01)00195278460271(11)231000(21)REV2X2300077CN

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category