GE Healthcare Revolution CT systems coolant leak creates slipping hazard
Certain GE Healthcare Revolution CT and Apex series systems may leak coolant fluid near the gantry base, creating a potential slip-fall hazard if left unnoticed.
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 recall involves a risk-of-harm product where a slip-fall hazard could occur if the leaked coolant is not noticed. No injuries or illnesses have been reported. The severity rubric places risk-of-harm products with unreported injury at score 3 (High).
Plain-English summary
GE Medical Systems is recalling certain Revolution Apex Plus and Revolution CT series computed tomography (CT) systems due to a potential coolant fluid leak. The coolant (glycol) can leak onto the floor near the base of the gantry.
The leaked fluid is blue in color, not corrosive, and not at a harmful temperature. However, if the fluid is not noticed, there is a potential for a person to slip and/or fall.
Four units of these systems are affected, with worldwide distribution. Specific system ID numbers, UDI codes, and lot/serial numbers are identified in the recall notice.
The recalled product
- Product
- GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — CT Imaging
- Hazard
- Affected units
- 4
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 (12)
- System ID Number 907729APEX1
- UDI (01)00195278460271(11)231100(21)REV2X2300082CN
- Mfg. Lot/Serial Number REV2X2300082CN
- System ID Number 336832APEX
- UDI (01)00195278460271(11)241000(21)REV2X2400129CN
- Mfg. Lot/Serial Number REV2X2400129CN
- System ID Number 973971CTREV
- UDI (01)00840682118552(11)160600(21)REVVX1600010CN
- Mfg. Lot/Serial Number REVVX1600010CN
- System ID Number 513584APEX1
- UDI (01)00840682146616(11)230300(21)REV2A2300023CN
- Mfg. Lot/Serial Number REV2A2300023CN
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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