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Class 2 Device Recall SoftLab version 4.01 ASCII Lab/Mic Addon |
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Date Initiated by Firm |
August 04, 2006 |
Date Posted |
October 20, 2010 |
Recall Status1 |
Terminated 3 on July 16, 2012 |
Recall Number |
Z-0100-2011 |
Recall Event ID |
56283 |
Product Classification |
Medical computers and software - Product Code LNX
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Product |
SoftLab version 4.01 ASCII, ASCII Base 3.1.3.0-3.1.3.32, 3.1.4-3.1.4.27, 3.1.6-3.1.6.4, 4.0.0.0-4.0.0.9; LAB/MIC Add-on 4.0.1, 4.0.1.0-4.0.1.13, 4.0.2.0 in 2006.
SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.
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Code Information |
SoftLab version 4.01 ASCII, ASCII Base 3.1.3.0-3.1.3.32, 3.1.4-3.1.4.27, 3.1.6-3.1.6.4, 4.0.0.0-4.0.0.9; LAB/MIC Add-on 4.0.1, 4.0.1.0-4.0.1.13, 4.0.2.0 in 2006. |
Recalling Firm/ Manufacturer |
SCC Soft Computer 5400 Tech Data Drive Clearwater FL 33760
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For Additional Information Contact |
727-789-0100
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Manufacturer Reason for Recall |
For SoftLab version 4.01 ASCII, the qualifying test result does not reach the Call List because the order is locked by either another application, or two Hosparams (HISRR_RBS_sync and Auto_sync_RBS). This creates a lock on the RBS server. The problem was identified in the RBS "C" rule which sends qualifying results to the Call List for SoftLab. All affected clients received the upgrade for Soft
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FDA Determined Cause 2 |
Software design |
Action |
SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to the affected client using SCC Soft Computer's proprietary Task Management System in June 2006. SCC recommended SoftLab version 4.01 ASCII users change program settings to prevent locking of the RBS server. A software upgrade with corrective patch will be delivered electronically to all clients. Client was asked to acknowledge receipt of the task and grant permission to load the required software. |
Quantity in Commerce |
131 |
Distribution |
Nationwide Distribution: USA in the states of AL, AR, CA, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NH, NJ, NY, OH, OK, PA, SD, TN, TX, VA, WA, WI, and WV. |
Total Product Life Cycle |
TPLC Device Report
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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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