Company: GE Medical Systems, LLC
Date of Enforcement Report 6/1/2016
Class lI:
PRODUCT
GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy..
Recall Number Z-1706-2016
REASON
Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.
RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI on 4/15/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
54
DISTRIBUTION
Nationwide and Internationally
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