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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
Voluntary/Mandated
Recall Initiation Date 2013-01-21
Initial Firm Notification of
Consignee or Public
Letter
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 4.0.0.26635 that if they were to re-occur, could cause a risk for patients. 1 Unit Z-0897-2013
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