Company:GE Healthcare, LLC
Date of Enforcement Report 3/6/2013
Class ll:
PRODUCT
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Recall Number Z-0761-2013
REASON
GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WA on 8/32012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
9 units installed in US
DISTRIBUTION
Nationwide
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