Z-0272-2012

IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular information system...

Name: Z-0272-2012 IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular information system...
Creator: AGFA Corp.
Published: 2011-06-06
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2011-06-06 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and... on 2011-06-06. The reason FDA records is "Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0272-2012
Status: Terminated
Initiated: 2011-06-06
Posted: 2011-11-23
Terminated: 2012-06-26
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it.
Root cause tag: software
FDA root cause: Software design
Action: An 'URGENT FIELD SAFETY NOTICE" was sent via FED-EX by June 6, 2011 to all the sites using the affected product. The letter described the issue and mitigation. The letter recommends that users not move reports to studies where a report already exists. If a report is being moved because the existing report is irrelevant to the study, then the existing report should be deleted prior to moving the new report to that study. If the report is being moved because the user wants to combine the content of the reports, then the "merge" function should be utilized. The letter also states that a software enhancement is currently available. Acknowledgment via FAX-Back was requested from the sites. Questions regarding the issue should be directed to customers' local Agfa HealthCare Service at 877-777-2432. The firm has identified 185 additional sites and an "URGENT FIELD SAFETY NOTICE" was sent on October 12, 2012.
Quantity in commerce: 323 units
Distribution: Worldwide Distribution -- USA, Virgin Islands and Canada
Product codes and lots: Software Versions 1.00.26, 1.00.27, CV7.4.SU3 and CV7.8.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)