Z-2184-2012Class II

IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report...

Name: Z-2184-2012 IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report...
Creator: AGFA Corp.
Published: 2012-07-27
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2012-07-27 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF) on 2012-07-27. FDA classified it as Class II and gives the reason as "Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report". 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-2184-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-27
Posted: 2012-08-10
Terminated: 2015-01-13
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
Root cause tag: software
FDA root cause: Software change control
Action: AGFA Healthcare sent an URGENT FIELD SAFETY NOTICE dated July 27, 2012, to all affected customers. The letter described the safety alert and mitigation. Customer were asked to complete the Acknowledgment form and fax back to 864-421-1664 that the information was received and understood. For questions customers were instructed tol call 401-604-2180. For questions regarding this recall call 864-421-1754.
Quantity in commerce: 280
Distribution: Worldwide Distribution - USA (nationwide) and Canada
Product codes and lots: Model # L9M2100 - All Software versions of IMPAX CV Reporting

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2184-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2184-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-10

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)