Events

Recall of Device Recall SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4.

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
    56272
  • Event Risk Class
    Class 2
  • Event Number
    Z-0102-2011
  • Event Initiated Date
    2009-01-26
  • Event Date Posted
    2010-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93108
  • 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 softpath gui versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4., the previous patient history and some qa management reports may have missing or incorrect diagnosis text. however, the patient final report, his resulting and query display are all correct. all affected clients have been provided corrected software.
  • Action
    SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to affected clients using SCC Soft Computer's proprietary Task Management System on January 26, 2009. SCC issued a software upgrade with corrective patch electronically to all clients. Client was asked to acknowledge receipt of the task and grant permission to load the required software. SCC will contact each client to coordinate the running of the utility and the loading and validation of the correct patch.

Device

Device Recall SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4.
  • Model / Serial
    SoftPath GUI versions 4.2.3.4, 4.2.4.1, 4.3.0.3, 4.3.0.4.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Throughout USA and Canada.
  • Product Description
    SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). || SoftPath GUI version 4.2.4.1 2008-09-30 (Manuf Date). || SoftPath GUI version 4.3.0.3, 2008-07-23 (Manuf Date). || SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf Date). || 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