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.
FDA Recall Z-1244-2008 · Posted 2008-09-11
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Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2007-05-14
Date Terminated2010-12-09
Product Quantity946 units (total)
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.
Firm Action
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
Distribution Pattern
U.S. Nationwide and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K053458WEB1000Agfa Corp. · 2005-12-22K050751IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.XAgfa Corp. · 2005-04-21K050228AGFA HEARTLAB CARDIOVASCULARHeartlab, Inc. · 2005-02-18K040555IMPAX CLIENT EMBRACEAgfa Corp. · 2004-05-26K022292IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHOAgfa Corp. · 2002-09-12
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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