Z-1069-2013Class II

IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation...

Name: Z-1069-2013 IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation...
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 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult... on 2013-03-15. FDA classified it as Class II and gives the reason as "Software design error in IMPAX CV 7.8 SU3". 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-1069-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-15
Posted: 2013-04-08
Terminated: 2014-04-01
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software design error in IMPAX CV 7.8 SU3
Root cause tag: software
FDA root cause: Software design
Action: AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated March 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to distribute this information within your facility to all individuals who need to be aware of this. Please fax back to (864) 421-1664 that the information was received and understood was requested from the customers. If you have any questions about this matter please contact your local AGFA Healthcare organization, or call (864) 421-1754.
Quantity in commerce: 2
Distribution: Distribute in the state of FL and KY
Product codes and lots: Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1069-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1069-2013	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)