FDA recall, , Moderate risk
GE Optima XR200amx, XR220amx and XR240amx Radiographic Systems
This could result in patient injury during an exam.
Summary by Recall Canary from the FDA notice
What happened
GE Medical Systems, LLC, of Waukesha, Wisconsin, began a recall on June 5, 2026, for certain Optima XR200amx, Optima XR220amx, and Optima XR240amx systems. In systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track.
The recall was added to the FDA's Enforcement Report on July 13, 2026, and distributed nationwide in the US and in Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, and the UK. The recall was classified by the FDA on July 13, 2026.
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?
3 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Optima XR200amx, Mobile Digital-Ready Radiographic System
- UDI-DI
- 00840682115278
Optima XR220amx, Mobile Digital-Ready Radiographic System
- UDI-DI
- 00840682115261
- 850070941
Optima XR240amx, Mobile Digital Radiographic System
- UDI-DI
- 00840682122351
- 00840682123686
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
- Company
- GE Medical Systems, LLCWaukesha, Wisconsin
- Hazard
- Device 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
- 99279
- Recall numbers
- Z-2726-2026 to Z-2728-2026
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
