Events

Recall of Device Recall SoftPath GUI version 3.17.6.3.1.

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
    56280
  • Event Risk Class
    Class 2
  • Event Number
    Z-0090-2011
  • Event Initiated Date
    2004-03-11
  • 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=93134
  • 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 clients using the softpath gui version 3.17.6.3.1 results reporting interface with parsed text and having the auto correct and auto formatting functions active in ms word, there is a possibility for some ansi characters/symbols to be translated incorrectly to ascii. scc soft computer initiated a correction in march 2004 for all affected clients.
  • 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 on March 11, 2007. SCC recommended turning off the autocorrect and autoformatting functions in MS Word if custom configuration parses text to an ASCII file (HIS) for the Result Reporting interface. If this function was turned on at the time of creating the canned message in the setup file, edit and re-save all canned messages in SoftPath. Client was asked to acknowledge receipt of the task and grant permission to load the required software correction.

Device

Device Recall SoftPath GUI version 3.17.6.3.1.
  • Model / Serial
    Version 3.17.6.3.1.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: One hospital in NY.
  • Product Description
    SoftPath GUI version 3.17.6.3.1. || SCC Soft Computer 34350 US Highway 19 N, Palm Harbor, FL 34684. || Date of Manufacture: || Version 3.17.6.3.1 06/03/2003.
  • 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