The Recall Desk
HighFDA (Devices)·Z-1302-2025·Announced 2025-03-19

GE Revolution CT Systems Potential Coolant Leak Slip-and-Fall Risk

GE Healthcare Revolution CT systems may leak glycol coolant near the gantry base. While the non-toxic fluid poses no chemical hazard, it creates a slip-and-fall risk if not noticed and cleaned.

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 recall for a risk-of-harm medical device (CT scanner system) where injury has not yet been reported. The coolant leak creates a potential slip-and-fall hazard, though the fluid itself is non-toxic and non-corrosive.

Plain-English summary

GE Healthcare has identified a potential issue in certain Revolution CT and Revolution Apex series CT systems. The systems may leak glycol coolant onto the floor near the gantry base. The fluid appears blue and is easily visible.

The coolant itself is not corrosive and is not at harmful temperature. However, the leaked fluid creates a wet surface that poses a slip-and-fall injury hazard if not noticed promptly and cleaned up. This risk is particularly relevant in busy clinical environments.

Approximately 105 affected systems have been identified and distributed worldwide. Affected healthcare facilities should inspect their systems for evidence of coolant leakage and ensure staff protocols are in place to promptly clean any fluid found.

GE Healthcare is investigating the root cause and developing a remedy for affected units. Healthcare facilities with affected systems should contact GE Healthcare for guidance on inspection and remediation.

The recalled product

Product
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
  • coolant-leak
  • slip-hazard

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 480342APEX
  • UDI (01)00840682146616(11)220900(21)REV2A2200072CN
  • Mfg. Lot/Serial Number REV2A2200072CN
  • 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 858657APEX
  • UDI (01)00840682118552(11)160900(21)REVVX1600034CN
  • Mfg. Lot/Serial Number REVVX1600034CN
  • 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

Distribution

Distribution scope not specified by the agency.

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