WEB1000 Versions 3.1, 4.1 and 5.1, 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-1244-2008
- Quantity
- 946 units (total)
- 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
WEB1000 version 3.1, Catalog Number: LD5GQ001; WEB1000 version 4.1, Catalog Number: LZS5R, LZS9Z, LZTA4 and WEB1000 version 5.1, Catalog Number: L7DOS, L7DLPU.
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.