Date Initiated by Firm | May 14, 2007 |
Date Posted | September 11, 2008 |
Recall Status1 |
Terminated 3 on December 09, 2010 |
Recall Number | Z-1244-2008 |
Recall Event ID |
46384 |
510(K)Number | K022292 K040555 K050228 K050751 K053458 |
Product Classification |
Picture Archiving and Communications system - Product Code LLZ
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Product | 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. |
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
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For Additional Information Contact | Ray 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 |
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) |
Distribution | U.S. Nationwide and Canada. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LLZ 510(K)s with Product Code = LLZ
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