FDA recall, , Moderate risk
GE HealthCare Revolution CT Scanners
GE HealthCare computed tomography systems have a potential security vulnerability that could impact AW Server via Edison Health Link.
Summary by Recall Canary from the FDA notice
What happened
GE Medical Systems, LLC, of Waukesha, Wisconsin, began a recall on March 26, 2026, of certain Revolution Apex, Revolution Ascend, and Revolution CT systems due to a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription. The recall was added to the FDA's Enforcement Report and classified on May 8, 2026, with distribution nationwide in the U.S. and worldwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
7 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
- UDI-DI
- 00840682123471
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
- UDI-DI
- 00840682146173
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
- UDI-DI
- 00195278469700
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
- UDI-DI
- 00195278460271
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
- UDI-DI
- 00840682146616
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
- UDI-DI
- 00195278502179
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
- UDI-DI
- 00840682118552
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution.
- Company
- GE Medical Systems, LLCWaukesha, Wisconsin
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98738
- Recall numbers
- Z-2149-2026 to Z-2155-2026
All recalls from GE Medical Systems, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
