Class 2 Device Recall SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.

• Date Initiated by Firm: February 23, 2006
• Date Posted: September 22, 2008
• Recall Status: Terminated on November 20, 2008
• Recall Number: Z-2463-2008
• Recall Event ID: 35372
• Product Classification: Calculator/data processing module for clinical use. - Product Code JQP
• Product: Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.
• Code Information: Version 1.2, 2.1, 2.2 and 2.3
• Recalling Firm/ Manufacturer: SCC Soft Computer; 5400 Tech Data Drive; Clearwater FL 33760
• For Additional Information Contact: 727-789-0100
• Manufacturer Reason for Recall: In the creation of revised report and supplemental reports diagnosis, text was inserted from another case.
• FDA Determined Cause: Software design
• Action: Consignees were notified of recall and provided with a software correction patch ICC number 3618.
• Quantity in Commerce: 201
• Distribution: Distributed to 106 consignees located throughout the United States 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.