The Recall Desk
Agency classClass IIOur severity: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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units
56

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.

Part of a larger recall action

This product is one of 7 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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