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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Product Detail

Product Description IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Recall Number Z-0035-2014
Classification Class II
Code Info N/A
Product Distributed Qty 4
Reason For Recall System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.

Event Detail

Event Id 66424
Product Type Devices
Status Terminated
Recalling Firm AGFA Corp.
City Greenville
State SC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.
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