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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description Ingenuity TF PET/CT Diagnostic imaging system
Recall Number Z-0897-2013
Classification Class II
Code Info Model # 882456, Serial # 2004.
Product Distributed Qty 1 Unit
Reason For Recall 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.

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.
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