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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Event Detail

Event ID 62796
Product Type Devices
Status Ongoing
Recalling Firm AGFA Corp.
City Greenville
State SC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-09
Initial Firm Notification of
Consignee or Public
Distribution Pattern USA Nationwide, Virgin Islands and Canada

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device All software versions of DICOMstore in combination with Media Purge Daemon (MPD) or Cardiovascular Purge Services (CPS). Class II Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa's Medical Image Storage Devices - Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS). 535 Z-2252-2012