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U.S. Department of Health and Human Services

Class 2 Device Recall SoftMic Versions 4.0.4.7 and 4.5.1.3

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  Class 2 Device Recall SoftMic Versions 4.0.4.7 and 4.5.1.3 see related information
Date Initiated by Firm July 19, 2010
Date Posted October 19, 2010
Recall Status1 Terminated 3 on July 16, 2012
Recall Number Z-0088-2011
Recall Event ID 56851
Product Classification Medical computers and software - Product Code LNX
Product SoftMic Versions 4.0.4.7, 4.5.1.3.
Version 4.0.4.7 Manufactured 02/03/2010.
Version 4.5.1.3 Manufactured 03/18/2010.
SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.
Code Information Versions 4.0.4.7, 4.5.1.3.
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
Softmic system may delay or omit reporting of clinically significant results including organisms and drug sensitivities. Incomplete culture results may appear complete. SCC Soft Computer is issuing a Correction for SoftMic Versions 4.0.4.7-4.5.1.3 software due to this potential hazard.
FDA Determined
Cause 2
Software design
Action SCC Soft Computer issued Risk-to-Health notifications to clients on July 19, 2010 via proprietary communication software. Corrective actions will be via programming correction via hot fix (software modification) or such so that Global variable is not used. Clients are asked to acknowledge receipt of this task and update the task with permission to load the required correction.
Quantity in Commerce 35
Distribution Worldwide Distribution: USA, including the states of CA, CT, DE, FL, IA, KY, MA, MA, MI, MN, NJ, NY, OH, PA, TX, VA, and WI, 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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