Company:Philips Medical Systems .
Date of Enforcement Report 4/10/2013
Class ll:
PRODUCT
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall Number Z-1029-2013
REASON
Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Cleveland, OH Malvern, PA, on 12/20/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1
DISTRIBUTION
Distributed to one customer in Ohio.
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