Z-1243-2008

IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiving and...

Name: Z-1243-2008 IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiving and...
Creator: AGFA Corp.
Published: 2007-05-14
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2007-05-14 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiving and Communications systems (PACs), used in the acceptance... on 2007-05-14. The reason FDA records is "Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost". 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-1243-2008
Status: Terminated
Initiated: 2007-05-14
Posted: 2008-09-11
Terminated: 2010-12-09
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiving and Communications systems (PACs), used in the acceptance, transfer, display, storage and digital processing of medical images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.
Root cause tag: software
FDA root cause: Software change control
Action: Agfa Healthcare contacted all consignees on 5/14/2007 and by registered mail on 06/07/2007. The registered Urgent Field Safety Notice letters requested the accounts take the following steps immediately: 1. Turn off automatic JAVA updates to avoid this update being applied in the background. 2. Do not manually update JAVA on their station-even for other applications. 3. If JAVA 1.6 has already been applied, do not use Service/Admin Tools. They were instructed to contact their IT department or Agfa support for assistance in backing out of this version to apply the required version for the Agfa software. A Mandatory Service Bulletin will inform and assist affected account in removing JAVA 1.6 if it has been applied and turning off the automatic updates via the JAVA Plug-in Control Panel.
Quantity in commerce: 946 units (total for both types of software)
Distribution: U.S. Nationwide and Canada.
Product codes and lots: IMPAX¿ 4.1, Catalog Number: LHZQN007; IMPAX ¿ 4.5, Catalog Number: LZTJM; IMPAX ¿ 5.0, Catalog Number: L3CJE; IMPAX ¿ 5.1 Catalog Number: L4AW6; IMPAX ¿ 5.2, Catalog Number: L4EM2; IMPAX ¿ 6.0, Catalog Number: L73V4; IMPAX ¿ 6.2, Catalog Number: EWMDT.

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)