Z-0033-2007

IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Name: Z-0033-2007 IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
Creator: AGFA Corp.
Published: 2006-08-08
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2006-08-08 / Terminated

FDA source

AGFA Corp. began a recall of IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis) on 2006-08-08. The reason FDA records is "Failed CAD displayed as 'No Findings'". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0033-2007
Status: Terminated
Initiated: 2006-08-08
Posted: 2006-10-12
Terminated: 2007-02-20
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Failed CAD displayed as 'No Findings'
FDA root cause: Other
Action: Consignees were notified by letter on/about 08/08/2006.
Quantity in commerce: 20 Impax 5.2 Mammo licenses were issued domestically.
Distribution: Nationwide.
Product codes and lots: Diagnostic Workstation/Impax 5.2/with CAD Capability/Flat Panel 60+00024433, Diagnostic Workstation/Impax 5.2/with CAD Capability/CRT: 60+00024432 and Clinical Review Station/Impax 5.2/with CAD Capability/Flat Panel: 60+00024438. Software version Impax 5.2.2 sites using CAD.

Product code LLZ

K022292Class IIImpax Diagnostic Display Station,impax Clinical Review Station,impax for Cardiology Clinical Review Satation,impax OrthoAgfa Corp. / cleared 2002-09-12

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)