Events

Recall of Device Recall SoftPath

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
    69837
  • Event Risk Class
    Class 2
  • Event Number
    Z-1065-2015
  • Event Initiated Date
    2014-11-26
  • Event Date Posted
    2015-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131609
  • 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
    Laboratory Information System - Product Code JQP
  • Reason
    Modifications to diagnostic text may be: 1) saved to the database but not appear on the report sent to the physician; or 2) documented on the report, but not saved to the database.
  • Action
    On 11/26/2014 SCC Soft Computer sent a Correction Communication to their consignees: Corrective Action: Versions 4.3.0.8 through 4.4.0.2 will have a mandatory hotfix created. Due to the amount of versions affected, the range of availability dates will be 11/24/2014 through 12/30/2014. Utility: A utility will be made available to be run on your Live system that will identify cases in which there is a disparity between the diagnosis text in the document and the database. The utility output will be provided for client review and validation.

Device

Device Recall SoftPath
  • Model / Serial
    Version 4.3.0.8 Release date: 07/31/2009 - Present;  Version 4.3.0.9 Release date: 11/23/2009 - Present;  Version 4.3.0.10 Release date: 09/20/2010- Present;  Version 4.3.0.11 Release date: 11/11/2010- Present;  Version 4.3.0.12 Release date: 02/07/2011- Present; Version 4.3.0.14 Release date: 11/14/2012- Present;  Version 4.3.0.15 Release date: 09/17/2013- Present;  Version 4.4.0.1 Release date: 12/13/2013 - Present;
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution US Nationwide and CANADA.
  • Product Description
    SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
  • 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