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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3. see related information
Date Initiated by Firm February 23, 2006
Date Posted September 22, 2008
Recall Status1 Terminated 3 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/
SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact
Manufacturer Reason
for Recall
In the creation of revised report and supplemental reports diagnosis, text was inserted from another case.
FDA Determined
Cause 2
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.