Events

Recall of Device Recall SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.

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
    35372
  • Event Risk Class
    Class 2
  • Event Number
    Z-2463-2008
  • 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=45946
  • 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
    In the creation of revised report and supplemental reports diagnosis, text was inserted from another case.
  • Action
    Consignees were notified of recall and provided with a software correction patch ICC number 3618.

Device

Device Recall SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.
  • Model / Serial
    Version 1.2, 2.1, 2.2 and 2.3
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to 106 consignees located throughout the United States and Canada.
  • Product Description
    Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.
  • 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