RecallDepth

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.

This recall has been terminated (originally issued October 19, 2010).

Company
Scc Soft Computer
Recall Initiated
March 11, 2004
Posted
October 19, 2010
Terminated
November 3, 2010
Recall Number
Z-0090-2011
Quantity
1
Firm Location
Clearwater, FL
Official Source
View on FDA website ↗

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.

Distribution

Nationwide distribution: One hospital in NY.

Lot / Code Info

Version 3.17.6.3.1.

Root Cause

Software design

Action Taken

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.

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