Z-1662-2014Class II

IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR)...

Name: Z-1662-2014 IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR)...
Creator: AGFA Corp.
Published: 2014-04-30
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2014-04-30 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital... on 2014-04-30. FDA classified it as Class II and gives the reason as "Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service". 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-1662-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-30
Posted: 2014-05-27
Terminated: 2014-09-18
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
Root cause tag: software
FDA root cause: Software design
Action: AGFA Healthcare sent an URGENT FIELD SAFETY NOTICE LETTER dated April 30, 2014, to the consignee describing the problem that had occurred, the actions being taken by Agfa and the actions Agfa has required the site to perform. As part of the correction Agfa requires the consignee to review the affected reports to confirm that the data is correct. If errors are found the consignee will need to correct the data. The consignee was asked to acknowledge, via FAX-Back to 864-421-1664 or email, that the information was received and understood by the consignee. For questions the consignee was instructed to contact their local Agfa HealthCare organization at 877-777-2432. For questions regarding this recall call 864-421-1754.
Quantity in commerce: One
Distribution: Distribution to SC only
Product codes and lots: Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - OCR Service

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1662-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1662-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-27

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)