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U.S. Department of Health and Human Services

Class 2 Device Recall SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4.

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  Class 2 Device Recall SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4. see related information
Date Initiated by Firm January 26, 2009
Date Posted October 20, 2010
Recall Status1 Terminated 3 on November 03, 2010
Recall Number Z-0102-2011
Recall Event ID 56272
Product Classification Medical computers and software - Product Code LNX
Product 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 version 4.3.0.3, 2008-07-23 (Manuf Date).
SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf Date).
SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.
Code Information SoftPath GUI versions 4.2.3.4, 4.2.4.1, 4.3.0.3, 4.3.0.4. 
Recalling Firm/
Manufacturer		 SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact
727-789-0100
Manufacturer 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..
FDA Determined
Cause 2		 Software design
Action 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.
Quantity in Commerce 52
Distribution Worldwide Distribution: Throughout USA and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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