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Recall Observatory FDA recall evidence

Device product

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

Z-2252-2012

August 09, 2012

Class II

Product summary

Firm
AGFA Corp.
Event
Event 62796
Status
Terminated
Classification
Class II
Quantity
535
Official record key
device-enforcement:Z-2252-2012

Official wording

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).

Code information: All software versions of DICOMstore in combination with Media Purge Daemon (MPD) or Cardiovascular Purge Services (CPS).

Distribution pattern: USA Nationwide, Virgin Islands and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).