Z-2252-2012Class II

AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge...

Name: Z-2252-2012 AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge...
Creator: AGFA Corp.
Published: 2012-08-09
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2012-08-09 / Terminated / root cause: manufacturing process

FDA source

AGFA Corp. began a recall of AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device on 2012-08-09. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2252-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-09
Posted: 2012-08-22
Terminated: 2015-12-08
Recalling firm: AGFA Healthcare Corp.
Product: AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
Product code: LLZ System, Image Processing, Radiological
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).
Root cause tag: manufacturing process
FDA root cause: Process design
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
Quantity in commerce: 535
Distribution: USA Nationwide, Virgin Islands and Canada
Product codes and lots: All software versions of DICOMstore in combination with Media Purge Daemon (MPD) or Cardiovascular Purge Services (CPS).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2252-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2252-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-22

Product code LLZ

K050228Class IIAgfa Heartlab CardiovascularHeartlab, Inc. / cleared 2005-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)