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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX

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  Class 2 Device Recall IMPAX see related information
Date Initiated by Firm May 14, 2007
Date Posted September 11, 2008
Recall Status1 Terminated 3 on December 09, 2010
Recall Number Z-1243-2008
Recall Event ID 46384
510(K)Number K022292  K050751  K053458  K040555  K050228  
Product Classification Picture Archiving and Communications system - Product Code LLZ
Product 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.
Code Information 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. 
Recalling Firm/
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Ray B. Myers Ph.D.
Manufacturer 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.
FDA Determined
Cause 2
Software change control
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.
Quantity in Commerce 946 units (total for both types of software)
Distribution U.S. Nationwide and Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = AGFA CORP.
510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.