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U.S. Department of Health and Human Services

Class 2 Device Recall WEB1000

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 Class 2 Device Recall WEB1000see related information
Date Initiated by FirmMay 14, 2007
Date PostedSeptember 11, 2008
Recall Status1 Terminated 3 on December 09, 2010
Recall NumberZ-1244-2008
Recall Event ID 46384
510(K)NumberK022292 K040555 K050228 K050751 K053458 
Product Classification Picture Archiving and Communications system - Product Code LLZ
ProductWEB1000 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.
Code Information 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.
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information ContactRay B. Myers Ph.D.
864-421-1815
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
ActionAgfa 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 Commerce946 units (total)
DistributionU.S. Nationwide and Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
510(K)s with Product Code = LLZ
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