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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64403
Product Type Devices
Status Ongoing
Recalling Firm Philips Medical Systems (Cleveland) Inc
City Cleveland
State OH
Country US
Recall Initiation Date 2013-01-21
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed only in Ohio.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Ingenuity TF PET/CT Diagnostic imaging system Model # 882456, Serial # 2004. Class II Issues have been detected in the Ingenuity TF PET/CT currently running Ingenuity TF PET/CT system software version that if they were to re-occur, could cause a risk for patients. 1 Unit Z-0897-2013