Company: Philips Medical Systems, Inc.
Date of Enforcement Report:2/122014
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
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.
Philips Medical Systems, Inc., Cleveland, OH on 12/4/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally