Home / Recalls / Medical Devices
GE Healthcare, LLC recalls GE Healthcare Definium 5000/5220493-2 X-Ray System
Recalled March 6, 2013 · FDA recall Z-0704-2013 · GE Healthcare
Hazard
When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated. · FDA Class II
Units
312 installed in US
Sold at
Nationwide Distribution
Description
When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.
Product
GE Healthcare Definium 5000/5220493-2 X-Ray System
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →