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

FDA device recall Z-1243-2008 · posted 2008-09-11 · Terminated

Recall details

Recalling firm

AGFA Corp.

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.

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.

Root cause

Software change control

Status

Terminated

Product code

LLZ

Quantity affected

946 units (total for both types of software)

Distribution

U.S. Nationwide and Canada.

Date initiated

2007-05-14

Date posted

2008-09-11

Date terminated

2010-12-09

Location

Greenville, SC

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