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.
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: 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
- Affected units
- 250
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.
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.
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