Z-0945-2009

IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers...

Name: Z-0945-2009 IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers...
Creator: AGFA Corp.
Published: 2008-12-24
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2008-12-24 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000... on 2008-12-24. The reason FDA records is "Polling procedure may fail when multiple merge/split is carried out". 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-0945-2009
Status: Terminated
Initiated: 2008-12-24
Posted: 2009-02-03
Terminated: 2010-04-01
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000. IMPAX Cardiovascular is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. The IMPAX Centric Polling Procedure provides a mechanism to ensure that patient demographic and merge/split operations performed on the IMPAX database utilizing the IMPAX Service Tool are captured and applied to the IMPAX CV database, in order to keep patient updates from the IMPAX database synchronized with the IMPAX CV database.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Polling procedure may fail when multiple merge/split is carried out.
Root cause tag: software
FDA root cause: Software design
Action: All sites potentially affected by this product were notified of the issue directly via telephone. Each site was directed to observe a ten minute polling window as an interim mitigation until the normal mitigation by software Service Update is performed at the site by Agfa Support. An Urgent Safety Notice was sent via FED-EX on/about 12/24/2008 to all sites. The letter describes the potential issue and both interim and formal mitigation. Acknowledgment, via FAX-Back, that the information was received and understood was requested from the sites.
Quantity in commerce: 5 units
Distribution: Nationwide Distribution --- including states of FL, IL, OR, SC, and SD.
Product codes and lots: Serial number: KQRCPF9, Equipment number: 15013696, ; Serial number: BQWBZ81, Equipment number: 10281800; Serial number: FB5C561, Equipment number: 10262174; Serial number: USE708NBP3, Equipment number: 15003839; and Serial number: GN6Z1E1, Equipment number: 15009724.

Product code LLZ

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)