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U.S. Department of Health and Human Services

Class 2 Device Recall SoftPath

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  Class 2 Device Recall SoftPath see related information
Date Initiated by Firm October 27, 2004
Date Posted July 27, 2006
Recall Status1 Terminated 3 on July 19, 2010
Recall Number Z-1243-06
Recall Event ID 35377
Product Classification diagnostic test result software - Product Code JQP
Product Product is SoftPath ASCII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinicial documentation and data processing.
Code Information Releases 2.3.0 and 4.3.7.
Recalling Firm/
Manufacturer		 SCC Soft Computer
34350 US Highway 19 N
Palm Harbor FL 34684-2149
Manufacturer Reason
for Recall		 Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a clinician/surgeon.
FDA Determined
Cause 2		 Other
Action Consignees were notified and the products were corrected by the firm.
Quantity in Commerce 4
Distribution Product was distributed to 4 clients, two in the United States and two in 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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