Z-1245-2008

IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer...

Name: Z-1245-2008 IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer...
Creator: AGFA Corp.
Published: 2007-06-28
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2007-06-28 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical... on 2007-06-28. The reason FDA records is "Text and Images may not be synchronized". 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-1245-2008
Status: Terminated
Initiated: 2007-06-28
Posted: 2008-09-11
Terminated: 2011-03-03
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Text and Images may not be synchronized.
Root cause tag: software
FDA root cause: Software design
Action: AGFA notified all consignees via registered letter on/about 06/28/2007 informing them of the potential problem and requesting the accounts ensure the visual synchronization indicators in the Text and Image Areas are used to verify the synchronization status of the Text and Image Areas. A FAX Back form was requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. A Mandatory Service Bulletin was deployed to correct the problem in the software.
Quantity in commerce: 154 units
Distribution: U.S. Nationwide and Canada
Product codes and lots: Software version IMPAX 6.2.1

Product code LLZ

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)