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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS). N/A Class II 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. 4 Z-0035-2014
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