Z-1887-2009

Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems...

Name: Z-1887-2009 Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems...
Creator: AGFA Corp.
Published: 2009-07-16
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2009-07-16 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems are used in the acceptance, transfer, display... on 2009-07-16. The reason FDA records is "Measurements are inaccurate on multiple workstations". 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-1887-2009
Status: Terminated
Initiated: 2009-07-16
Posted: 2009-09-08
Terminated: 2011-04-28
Recalling firm: AGFA Healthcare Corp.
Product: Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images. Primary users are radiologists, mammographers, orthopaedists and other trained medical staff.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Measurements are inaccurate on multiple workstations.
Root cause tag: software
FDA root cause: Software design
Action: Agfa Healthcare issued an "URGENT FIELD SAFETY NOTICE" dated July 16, 2009. The notice informed of the problem and provided details to identify potentially compromised data that could result in measurement inaccuracies. A feedback form was provided to be completed and returned to the firm. For further information, contact Agfa Healthcare at 1-773-592-4769.
Quantity in commerce: One unit
Distribution: Nationwide Distribution -- IL
Product codes and lots: Product Version 6.3.1 SU10.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)