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.
- Company
- Agfa Corp.
- Recall Initiated
- May 14, 2007
- Posted
- September 11, 2008
- Terminated
- December 9, 2010
- Recall Number
- Z-1243-2008
- Quantity
- 946 units (total for both types of software)
- Firm Location
- Greenville, SC
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.
Distribution
U.S. Nationwide and Canada.
Lot / Code Info
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.
Root Cause
Software change control
Action Taken
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.