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Revolution recallZ-1301-2025 · GE Medical Systems, LLC · initiated Feb 18, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process change control

What the company is doing

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/18/2025 via letter delivered using a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken: "You can continue to use your system. Please monitor the floor near the base of the gantry for any accumulation of blue fluid. If blue fluid is observed, wear nitrile or rubber gloves, clean up the fluid by absorbing it with a noncombustible absorbent material, and dispose of the absorbent material in a suitable container for disposal. Please contact your local GE HealthCare service representative if any blue fluid is observed. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please complete and return the attached acknowledgement form to [email protected]."

Recall details

Recall number
Z-1301-2025
Status
Open, Classified
Initiated by the company
Feb 18, 2025
Posted by the FDA
Mar 7, 2025
Recalling firm
GE Medical Systems, LLC
Quantity
1 unit
Product code
JAK
FDA submissions
K213715
Distribution
Worldwide distribution.

Product description

GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed

Code information (models, lots, serial numbers)

System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K213715 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96370).

Sources and updates

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