Company:AGFA Corp. .
Date of Enforcement Report 8/29/12
Class ll:
PRODUCT
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
REASON
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).
RECALLING FIRM/MANUFACTURER
AGFA Corp. Greenville, SC on 8/9/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
535 units
DISTRIBUTION
Nationwide, Virgin Islands and Canada
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