GE Healthcare Revolution Apex Select recall
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
Why was GE Healthcare Revolution Apex Select recalled?
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN
- Product
- GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 1 unit
- Distribution
- Worldwide distribution.
- Recall date
- March 19, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)