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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/
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 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.
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