Z-2652-2017Class II

IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI)...

Name: Z-2652-2017 IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI)...
Creator: AGFA Healthcare Corp.
Published: 2016-12-22
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2016-12-22 / Terminated / root cause: software

FDA source

AGFA Healthcare Corp. began a recall of IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and... on 2016-12-22. FDA classified it as Class II and gives the reason as "A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm". 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-2652-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-22
Posted: 2017-06-29
Terminated: 2021-08-27
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
Product code: LLZ System, Image Processing, Radiological
Reason for recall: A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
Root cause tag: software
FDA root cause: Software design
Action: AGFA Healthcare sent an Urgent Field Safety Notice dated December 22, 2016, to all affected consignees. The notice included an acknowledgement fax-back or email indicating that the information was received and understood. The notice informed the consignees of the problem and indicated that they would be contacted by Agfa Service to check the problem and to correct the NIV reporting clinical content. Customers with questions were instructed to call 1-401-330-7433. For questions regarding this recall call 864-421-1984.
Quantity in commerce: 10
Distribution: Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI
Product codes and lots: Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2652-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2652-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29

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)