Company:Philips Medical Systems Inc.
Date of Enforcement Report 3/6/2013
Class ll:
PRODUCT
Ingenuity TF PET/CT Diagnostic imaging system Recall Number Z-0897-2013
REASON
Issues have been detected in the Ingenuity TF PET/CT currently running Ingenuity TF PET/CT system software version 4.0.0.26635 that if they were to re-occur, could cause a risk for patients.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Inc., Cleveland, OH on 1/21/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Ohio
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