Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0090-2011

SoftPath GUI version 3.17.6.3.1. SCC Soft Computer 34350 US Highway 19 N, Palm Harbor, FL 34684. Date of...

SCC Soft Computer / initiated 2004-03-11 / Terminated / root cause: software

SCC Soft Computer began a recall of 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 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0090-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
SCC Soft Computer
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.
Product code
LNX
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.
Root cause tag
software
FDA root cause
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.
Product codes and lots
Version 3.17.6.3.1.