Events

Recall of Device Recall Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1

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
    56274
  • Event Risk Class
    Class 2
  • Event Number
    Z-0074-2011
  • Event Initiated Date
    2004-11-30
  • Event Date Posted
    2010-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93113
  • 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
    Soft query results reporting versions 2.2.0.6.3 and 2.2.0.7.1 his may display incorrect collection data for a procedure or test result. clients using hbo star rr interface to query for results on a canceled test may see the previous occurrence of the test with the current date and time displayed as the collection date and time instead of the correct collection date and time sent by the scc interf.
  • Action
    Client Notification Task Verbiage was sent through the Task Management System on December 3, 2003, identifying the software issue, the clinical impact, and corrective action. Customers were informed that the HIS may display incorrect collection data. Customers received the SQRR Service Pack with revised software, which will will not produce inaccurate information if there are no verified results. Customers were to acknowledge receipt of the task notification and indicate whether they would like the corrected software. SCC Soft Computer proprietary Task Management System is used to manage client communication. Clients use this system to request services, receive and provide software updates for any issue. Customers can contact SCC Soft Computer at 727-789-0100.

Device

Device Recall Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1
  • Model / Serial
    Versions 2.2.0.6.3 and 2.2.0.7.1.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: including states of GA, LA, and NH.
  • Product Description
    Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Soft Query Results Reporting version 2.2.0.6.3 was released for General Availability on 09/11/03. || Soft Query Results Reporting version 2.2.0.7.1 was released for General Availability on 01/08/04.
  • 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