Events

Recall of Device Recall SoftMic Versions 4.0.4.7 and 4.5.1.3

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
    Recall
  • Event ID
    56851
  • Event Risk Class
    Class 2
  • Event Number
    Z-0088-2011
  • Event Initiated Date
    2010-07-19
  • Event Date Posted
    2010-10-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94639
  • 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
    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.
  • 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.

Device

Device Recall SoftMic Versions 4.0.4.7 and 4.5.1.3
  • Model / Serial
    Versions 4.0.4.7, 4.5.1.3.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    SCC Soft Computer

Manufacturer

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