Recall of SoftLab version 4.01 ASCII Lab/Mic Addon

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SCC Soft Computer.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Medical computers and software - Product Code LNX
  • Reason
    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.
  • 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.


  • Model / Serial
    SoftLab version 4.01 ASCII, ASCII Base, 3.1.4-, 3.1.6-,; LAB/MIC Add-on 4.0.1,, in 2006.
  • Product Classification
  • Device Class
  • Implanted device?
  • 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.
  • Product Description
    SoftLab version 4.01 ASCII, ASCII Base, 3.1.4-, 3.1.6-,; LAB/MIC Add-on 4.0.1,, in 2006. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.
  • Manufacturer


  • Manufacturer Address
    SCC Soft Computer, 5400 Tech Data Drive, Clearwater FL 33760
  • Manufacturer Parent Company (2017)
  • Source