Events

Recall of Device Recall SoftWeb Version 4.0.4.10.1

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
    56282
  • Event Risk Class
    Class 2
  • Event Number
    Z-0099-2011
  • Event Initiated Date
    2006-06-08
  • Event Date Posted
    2010-10-20
  • 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=93136
  • 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
    If a case number is re-used in softweb with softpath, the softpath case is linked to the original mrn in softweb. this causes softpath cases being linked to the wrong patient in softweb. incorrect results on the patient with original mrn and no results on the patient with the second mrn (and the reused case number) are displayed in softweb results query. scc soft computer issued a correction for.
  • 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 June 8, 2006. SCC recommended SoftPath/SoftWeb users NOT re-use SoftPath case numbers when cases are cancelled. The generic option setting "Specimen Registration - Standard Settings - Minimum Time to Reactivate Case Number" should be set to "0" so the user is not prompted to reuse the same case number. Client was asked to acknowledge receipt of the task and grant permission to load the required software correction.

Device

Device Recall SoftWeb Version 4.0.4.10.1
  • Model / Serial
    version 4.0.4.10.1.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: 1 hospital in Alaska.
  • Product Description
    SoftWeb version 4.0.4.10.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Manufacture Date: 05/16/2006.
  • 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