Recall Z-0704-2013— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-09-26, terminated 2013-12-05. FDA's recall record names no specific 510(k) clearance for this event. Product: GE Healthcare Definium 5000/5220493-2 X-Ray System. Reason: 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..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-26
- Terminated
- 2013-12-05
- Firm location
- Waukesha, WI, United States
Product description
GE Healthcare Definium 5000/5220493-2 X-Ray System
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.