FDA-Device2012-08-29Class II

AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device

AGFA Corp.
Hazard

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).

Sold states
USA Nationwide, Virgin Islands and Canada
Affected count
535
Manufactured in
10 S Academy St, N/A, Greenville, SC, United States
Products
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2252-2012

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