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.
This recall has been terminated (originally issued September 11, 2008).
- 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
- Official Source
- View on FDA website ↗
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.