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U.S. Department of Health and Human Services

Class 2 Device Recall SoftPath GUI Versions 3.17 and 4.1

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  Class 2 Device Recall SoftPath GUI Versions 3.17 and 4.1 see related information
Date Initiated by Firm December 30, 2003
Date Posted October 19, 2010
Recall Status1 Terminated 3 on November 03, 2010
Recall Number Z-0089-2011
Recall Event ID 56277
Product Classification Medical computers and software - Product Code LNX
Product SoftPath GUI Versions 3.17 and 4.1.
SCC Soft Computer 5400 Tech Data Drive, Clearwater, FL 33760.

Manufactured: Version 3.17.7.6 10/23/2003
Code Information Version 3.17.7.6
Recalling Firm/
Manufacturer		 SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact
727-789-0100
Manufacturer Reason
for Recall		 SoftPath Cases with Word Perfect documents that were not signed out in ASCII are printing in GUI as a converted document from Word Perfect to PDF document instead of the current MS Word Document. This affects clients upgrading from ASCII to SoftPath GUI 3.17.7.6 Version. All affected clients have been notified and corrections have been made.
FDA Determined
Cause 2		 Software design
Action SCC Soft Computer issued Risk-to-Health notifications with Client Notification Verbiage to affected clients using SCC Soft Computer's proprietary Task Management System. beginning on December 30, 2003. Clients were instructed to sign out all Word Perfect documents before upgrading to GUI. The correction for this anomaly is to upgrade to the latest release of version 3.17.7 or 3.17.8. Clients were asked to acknowledge receipt of this Task and indicate whether they would like to take the correction at this time. When the client decides to accept the correction a new task will be created to initiate the patch using the Task Management System.
Quantity in Commerce 5
Distribution Nationwide Distribution to the states of IN, NC, NH, and NJ.
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.
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