The Recall Desk
HighFDA (Devices)·Z-1299-2025·Announced 2025-03-19

GE Healthcare CT Systems May Leak Coolant Fluid on Floor

GE Healthcare Revolution CT and Apex series systems can leak coolant fluid onto the floor near the gantry, creating a slip and fall hazard. The blue-colored fluid is non-corrosive and not hot, but poses injury risk 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: FDA Class II recall with potential slip and fall hazard. No injuries have been reported, and the fluid is non-corrosive and not at harmful temperature. Per the rubric, this qualifies as High (3): a risk-of-harm product where injury has not yet been reported.

Plain-English summary

GE Healthcare has issued a recall for certain Revolution CT and Revolution Apex series computed tomography (CT) systems. The affected units may leak coolant fluid (glycol) near the base of the gantry.

The leaked fluid is visible as a blue-colored liquid. While the fluid itself is not corrosive and is not at a harmful temperature, it can create a slip and fall hazard if not noticed and cleaned up promptly.

The recall affects 42 units distributed worldwide. Affected systems can be identified by their specific System ID numbers and manufacturing lot numbers listed in the official recall notice.

Healthcare facilities and operators of affected CT systems should inspect their equipment for signs of coolant leaks around the gantry base. Any visible fluid should be cleaned up immediately to prevent slip and fall injuries. Contact GE Healthcare for further guidance on inspection and service procedures.

The recalled product

Product
GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — CT Scanner
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 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

Distribution

Distribution scope not specified by the agency.

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