Product Wiki · Recalls · U.S. FDA — Device Enforcement

AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV… — recall Z-2252-2012

U.S. FDA — Device Enforcement · United States · 2012-08-09 · Class II

As described by U.S. FDA — Device Enforcement: AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2252-2012
Date of alert
2012-08-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
AGFA Corp.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
USA Nationwide, Virgin Islands and Canada
Reported risk: 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).
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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