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U.S. Department of Health and Human Services

Class 2 Device Recall SoftPath GUI

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  Class 2 Device Recall SoftPath GUI see related information
Date Initiated by Firm July 20, 2011
Date Posted December 02, 2011
Recall Status1 Terminated 3 on May 21, 2013
Recall Number Z-0363-2012
Recall Event ID 60458
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12.

SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.
Code Information SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12.
Recalling Firm/
Manufacturer		 SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact Kathryn Branca
727-789-0100
Manufacturer Reason
for Recall		 On 07/20/2011 SCC Soft Computer, Clearwater, FL, initiated a correction on the following SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. A client reported that the HPV results on a patient report were incorrect. The HPV results were from the previous order on the patient and not the current order. All affected clients were notified about the issue on 07/20/2011.
FDA Determined
Cause 2		 Software design
Action SCC Soft Computer sent a "CORRECTION COMMUNICATION" dated July 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. SCC personnel will review the customized Lab Results AP macro and/or the Micro Results AP macro on customer systems and will either discuss with them the irregularities requiring change or reconfigure macros as necessary.
Quantity in Commerce 97
Distribution Worldwide Distribution-USA (nationwide) 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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