Events

Recall of Device Recall SoftPath GUI Release Software 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
    35369
  • Event Risk Class
    Class 2
  • Event Number
    Z-2329-2008
  • Event Initiated Date
    2006-02-23
  • Event Date Posted
    2008-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45939
  • 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
    Calculator/data processing module for clinical use. - Product Code JQP
  • Reason
    Loss of text misrepresented individual tissue diagnosis on the final diagnosis print out from the his system software. the specimen heading "j" was removed and the diagnosis appeared under the specimen heading "i" as a result the specimen with the heading "i" had two diagnosis.
  • Action
    Software corrections were sent as of 10/30/2003 for clients to upgrade to, the correction software patch is in versions 3.17.5.16, 3.17.6.10, 3.17.7.3 and 4.1.1.0. The firm did not inform the non-affected consignees of the failure because the firm concluded that the associated risk was low.

Device

Device Recall SoftPath GUI Release Software Versions 3.17 and 4.1
  • Model / Serial
    Versions 3.17 and 4.1
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and the country of Canada.
  • Product Description
    SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases.
  • 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