Z-1070-2013Class II

IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital...

Name: Z-1070-2013 IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital...
Creator: AGFA Corp.
Published: 2013-03-15
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2013-03-15 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and... on 2013-03-15. FDA classified it as Class II and gives the reason as "Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system". 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-1070-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-15
Posted: 2013-04-08
Terminated: 2014-01-09
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.
Root cause tag: software
FDA root cause: Software design
Action: AGFA sent an "URGENT FIELD SAFETY NOTICE" letter dated March 15, 2013 to the consignees who use the IMPAX CV Reporting tool described for this issue. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 877-777-2432, referencing HQ_10020006 for questions regarding this notice.
Quantity in commerce: 26
Distribution: Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.
Product codes and lots: Model # L9M21000. Software versions: IMPAX CV 7.8, 7.8 SU1, 7.8 SU2 and 7.8 SU3, IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1070-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1070-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-08

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)