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Terminated

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

FDA Recall Z-2252-2012 · Posted 2012-08-22

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-08-09
Date Terminated2015-12-08
Product Quantity535

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).

Firm Action

On 8/9/2012 AGFA Healthcare issued an "URGENT FIELD SAFETY NOTICE" letter to consignees. This letter describes the problem and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood was also required from the consignees

Root Cause

Process design

Distribution Pattern

USA Nationwide, Virgin Islands and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050228AGFA HEARTLAB CARDIOVASCULARHeartlab, Inc. · 2005-02-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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