Company: Philips Medical Systems, Inc.
Date of Enforcement Report:2/122014
Class lI:
PRODUCT
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
Recall Number Z-0932-2014
REASON
The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 12/4/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
386 units
DISTRIBUTION
Nationwide and Internationally
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