Z-2069-2012Class II

IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective...

Name: Z-2069-2012 IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective...
Creator: AGFA Corp.
Published: 2012-07-10
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2012-07-10 / Terminated / root cause: labeling and UDI

FDA source

AGFA Corp. began a recall of IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult... on 2012-07-10. FDA classified it as Class II and gives the reason as "When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2069-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-10
Posted: 2012-07-24
Terminated: 2013-10-29
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: AGFA Healthcare sent an Urgent Field Safety Notice dated July 10, 2012, to all affected consignees indicating that a representative from the IMPAX CV product management or professional services team would be contacting them to perform a review of their system. For questions customers were asked to call 401-604-2180. For questions regarding this recall call 864-421-1754.
Quantity in commerce: 6
Distribution: Nationwide Distribution including IN, SC, OH, TX
Product codes and lots: Software Version: RM 2.03 to 2.08, NIV 1.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2069-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2069-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-24

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)