Company:GE Healthcare LLC
Date of Enforcement Report 9/19/12
Class ll:
PRODUCT
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body. Recall Number Z-2255-2012
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/MANUFACTURER
Capintec Inc., Waukesha WI on 7/10/2012. Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
254 units
DISTRIBUTION
Nationwide
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