FDA Device

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.

Hazard

Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.

What You Should Do

Remedy

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.

Products

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 pr
Brand
AGFA Corp.
UPC
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.

Units Affected

946 units (total for both types of software)