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U.S. Department of Health and Human Services

Class 2 Device Recall SoftPath GUI version 3.17.6.3.1.

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  Class 2 Device Recall SoftPath GUI version 3.17.6.3.1. see related information
Date Initiated by Firm March 11, 2004
Date Posted October 19, 2010
Recall Status1 Terminated 3 on November 03, 2010
Recall Number Z-0090-2011
Recall Event ID 56280
Product Classification Medical computers and software - Product Code LNX
Product SoftPath GUI version 3.17.6.3.1.
SCC Soft Computer 34350 US Highway 19 N, Palm Harbor, FL 34684.

Date of Manufacture:
Version 3.17.6.3.1 06/03/2003.
Code Information Version 3.17.6.3.1. 
Recalling Firm/
Manufacturer		 SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact
727-789-0100
Manufacturer Reason
for Recall		 For clients using the SoftPath GUI version 3.17.6.3.1 Results Reporting interface with parsed text and having the auto correct and auto formatting functions active in MS Word, there is a possibility for some ANSI characters/symbols to be translated incorrectly to ASCII. SCC Soft Computer initiated a Correction in March 2004 for all affected clients.
FDA Determined
Cause 2		 Software design
Action SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to the affected client using SCC Soft Computer's proprietary Task Management System on March 11, 2007. SCC recommended turning off the autocorrect and autoformatting functions in MS Word if custom configuration parses text to an ASCII file (HIS) for the Result Reporting interface. If this function was turned on at the time of creating the canned message in the setup file, edit and re-save all canned messages in SoftPath. Client was asked to acknowledge receipt of the task and grant permission to load the required software correction.
Quantity in Commerce 1
Distribution Nationwide distribution: One hospital in NY.
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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