Recall Z-2256-2012— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-07-10, terminated 2013-01-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.. Reason: Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-10
- Terminated
- 2013-01-10
- Firm location
- Waukesha, WI, United States
Product description
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Reason for recall
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.