SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). SoftPath GUI version 4.2.4.1 2008-09-30 (Manuf Date). SoftPath GUI

FDA device recall Z-0102-2011 · posted 2010-10-20 · Terminated

Recall details

Recalling firm

SCC Soft Computer

Reason for recall

For SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4., the Previous Patient History and some QA Management reports may have missing or incorrect diagnosis text. However, the patient final report, HIS resulting and Query display are all correct. All affected clients have been provided corrected software..

Action taken

SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to affected clients using SCC Soft Computer's proprietary Task Management System on January 26, 2009. SCC issued a software upgrade with corrective patch electronically to all clients. Client was asked to acknowledge receipt of the task and grant permission to load the required software. SCC will contact each client to coordinate the running of the utility and the loading and validation of the correct patch.

Root cause

Software design

Status

Terminated

Product code

LNX

Quantity affected

52

Distribution

Worldwide Distribution: Throughout USA and Canada.

Date initiated

2009-01-26

Date posted

2010-10-20

Date terminated

2010-11-03

Location

Clearwater, FL