The Recall Desk
HighFDA (Devices)·Z-1297-2025·Announced 2025-03-19

GE Healthcare Revolution CT Systems: Coolant Fluid Leak Creates Slip Hazard

GE Healthcare Revolution Apex and Revolution CT series systems may leak coolant fluid onto the floor near the gantry. The blue-colored, non-toxic fluid poses a slip and fall hazard if not noticed.

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: This is a Class II FDA recall of a risk-of-harm medical device where no injuries or illnesses have been reported. The slip and fall hazard is real but remains theoretical. Per the severity rubric, this meets the criteria for score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare has identified a potential coolant leak issue on certain Revolution Apex and Revolution CT series computed tomography systems. Approximately 56 units distributed worldwide are subject to this recall.

The systems can develop coolant fluid (glycol) leaks near the base of the gantry. The leaked fluid is blue in color. Although the fluid is not corrosive and not at a harmful temperature, it presents a slip and fall hazard if not noticed and removed.

This recall is being issued to inform healthcare facilities and providers of this potential issue with affected equipment.

The recalled product

Product
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Computed Tomography System
Hazard
  • slip-and-fall-hazard
  • fluid-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: 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
  • Mfg. Lot/Serial Number REV2X2300074CN
  • System ID Number: 617726Y6REV2
  • UDI (01)00840682118552(11)170900(21)REVVX1700090CN
  • Mfg. Lot/Serial Number REVVX1700090CN

Distribution

Distribution scope not specified by the agency.

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