Z-1434-2011

Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system...

Name: Z-1434-2011 Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system...
Creator: AGFA Corp.
Published: 2011-01-27
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2011-01-27 / Terminated

FDA source

AGFA Corp. began a recall of Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and... on 2011-01-27. The reason FDA records is "Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1434-2011
Status: Terminated
Initiated: 2011-01-27
Posted: 2011-02-24
Terminated: 2011-03-29
Recalling firm: AGFA Healthcare Corp.
Product: Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports.
FDA root cause: Other
Action: The firm, AGFA Healthcare, sent a "Safety Notice" dated January 27, 2011 to all customers. The notice described the product, problem and action to be taken by firm and customer. AGFA informed the customers that a software upgrade was made between December 2008 and February 2010 and instructed the customers to distribute this information to all individuals within their facility and to complete and return the attached URGENT SAFETY NOTICE FEEDBACK FORM via fax to 864-421-1664 or email to [email protected]. Note: Service Bulletin DD+DIS100.09E, was issued March 2009 and an upgrade from Software Versions 2.12.05 through 2.14.03.SU1 to Software Version CRS 2.14.03.SU2 was required for the impacted sites. Most identified consignees/customers required the software upgrade, but some consignees/customers had already been upgraded prior to the event and did not require additional upgrades. If you have any questions about this matter, please contact the Post Market/QARA North America via email at [email protected] or call at 864-421-1754.
Quantity in commerce: 107
Distribution: Worldwide distribution: USA and country of: Canada
Product codes and lots: Software Versions 2.12.05 - 2.14.03.SU1

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)