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

FDA device recall Z-0090-2011 · posted 2010-10-19 · Terminated

Recall details

Recalling firm

SCC Soft Computer

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.

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.

Root cause

Software design

Status

Terminated

Product code

LNX

Quantity affected

1

Distribution

Nationwide distribution: One hospital in NY.

Date initiated

2004-03-11

Date posted

2010-10-19

Date terminated

2010-11-03

Location

Clearwater, FL