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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
Recall Number Z-2252-2012
Classification Class II
Code Info All software versions of DICOMstore in combination with Media Purge Daemon (MPD) or Cardiovascular Purge Services (CPS).
Product Distributed Qty 535
Reason For Recall 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).

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 Letter
Distribution Pattern USA Nationwide, Virgin Islands and Canada