Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0089-2011

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

SCC Soft Computer / initiated 2003-12-30 / Terminated / root cause: software

SCC Soft Computer began a recall of SoftPath GUI Versions 3.17 and 4.1. SCC Soft Computer 5400 Tech Data Drive, Clearwater, FL 33760. Manufactured: Version 3.17.7.6 10/23/2003 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0089-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
SCC Soft Computer
Product
SoftPath GUI Versions 3.17 and 4.1. SCC Soft Computer 5400 Tech Data Drive, Clearwater, FL 33760. Manufactured: Version 3.17.7.6 10/23/2003
Product code
LNX
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.
Root cause tag
software
FDA root cause
Software design
Action
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.
Quantity in commerce
5
Distribution
Nationwide Distribution to the states of IN, NC, NH, and NJ.
Product codes and lots
Version 3.17.7.6