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U.S. Department of Health and Human Services

Class 2 Device Recall SoftPath GUI Release Software Versions 3.17 and 4.1

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  Class 2 Device Recall SoftPath GUI Release Software Versions 3.17 and 4.1 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-2329-2008
Recall Event ID 35369
Product Classification Calculator/data processing module for clinical use. - Product Code JQP
Product SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases.
Code Information Versions 3.17 and 4.1
Recalling Firm/
Manufacturer		 SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact
727-789-0100
Manufacturer Reason
for Recall		 Loss of text misrepresented individual tissue diagnosis on the final diagnosis print out from the HIS system software. The specimen heading "J" was removed and the diagnosis appeared under the specimen heading "I" as a result the specimen with the heading "I" had two diagnosis.
FDA Determined
Cause 2		 Other
Action Software corrections were sent as of 10/30/2003 for clients to upgrade to, the correction software patch is in versions 3.17.5.16, 3.17.6.10, 3.17.7.3 and 4.1.1.0. The firm did not inform the non-affected consignees of the failure because the firm concluded that the associated risk was low.
Quantity in Commerce 335
Distribution Worldwide Distribution including USA and the country of 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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