Events

Recall of Device Recall SoftPath GUI Versions 3.17 and 4.1

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
    56277
  • Event Risk Class
    Class 2
  • Event Number
    Z-0089-2011
  • Event Initiated Date
    2003-12-30
  • Event Date Posted
    2010-10-19
  • 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=93122
  • 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
    Softpath cases with word perfect documents that were not signed out in ascii are printing in gui as a converted document from word perfect to pdf document instead of the current ms word document. this affects clients upgrading from ascii to softpath gui 3.17.7.6 version. all affected clients have been notified and corrections have been made.
  • Action
    SCC Soft Computer issued Risk-to-Health notifications with Client Notification Verbiage to affected clients using SCC Soft Computer's proprietary Task Management System. beginning on December 30, 2003. Clients were instructed to sign out all Word Perfect documents before upgrading to GUI. The correction for this anomaly is to upgrade to the latest release of version 3.17.7 or 3.17.8. Clients were asked to acknowledge receipt of this Task and indicate whether they would like to take the correction at this time. When the client decides to accept the correction a new task will be created to initiate the patch using the Task Management System.

Device

Device Recall SoftPath GUI Versions 3.17 and 4.1
  • Model / Serial
    Version 3.17.7.6
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to the states of IN, NC, NH, and NJ.
  • Product Description
    SoftPath GUI Versions 3.17 and 4.1. || SCC Soft Computer 5400 Tech Data Drive, Clearwater, FL 33760. || Manufactured: Version 3.17.7.6 10/23/2003
  • 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