GE Healthcare Revolution CT systems recalled for potential coolant leaks
GE Healthcare is recalling Revolution CT and Revolution Apex series systems due to potential coolant fluid leaks from the gantry base, which could create a slip and fall hazard.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Precautionary FDA Class II recall for potential slip and fall hazard from leaked coolant. No injuries or illnesses are reported in the source. The low-consequence nature of the hazard supports Moderate severity.
Plain-English summary
GE Healthcare has identified a potential issue affecting certain Revolution CT and Revolution Apex series computed tomography systems with worldwide distribution. The systems can leak coolant fluid (glycol) onto the floor near the base of the gantry.
The leaked coolant appears as a blue fluid. GE HealthCare notes the fluid is not corrosive and poses no thermal hazard. However, if the leaked fluid is not noticed, a person could slip and fall on the floor, creating a potential for injury.
The recalled product
- Product
- GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — CT Scanner
- Hazard
- Affected units
- 1
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 (3)
- System ID Number 907729APEX1
- UDI (01)00195278460271(11)231100(21)REV2X2300082CN
- Mfg. Lot/Serial Number REV2X2300082CN
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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