SoftPath GUI Versions 3.17 and 4.1. SCC Soft Computer 5400 Tech Data Drive, Clearwater, FL 33760. Manufactured: Version

FDA device recall Z-0089-2011 · posted 2010-10-19 · Terminated

Recall details

Recalling firm

SCC Soft Computer

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

LNX

Quantity affected

5

Distribution

Nationwide Distribution to the states of IN, NC, NH, and NJ.

Date initiated

2003-12-30

Date posted

2010-10-19

Date terminated

2010-11-03

Location

Clearwater, FL