Events

Recall of Device Recall SoftID.NET versions 2.0.0.6 2.0.0.19.

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
    56873
  • Event Risk Class
    Class 2
  • Event Number
    Z-0360-2011
  • Event Initiated Date
    2009-08-28
  • Event Date Posted
    2010-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94758
  • 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 LNX
  • Reason
    Scc soft computer issued a correction for softid.Net versions 2.0.0.6 - 2.0.0.19. when using the cancel functionality, if the collection list refreshes during the transaction and changes the position of the patient on the list, the wrong patient order can be cancelled. all affected clients have been notified.
  • Action
    SCC Soft Computer notified Customers on August 28, 2009, via the proprietary communication software entitled "Risk-to-Health Notification Task Verbiage" dated August 17, 2009. The notification described the product, problem and action to be taken by customer. The customers were instructed to acknowledge receipt of the notification; document a request to load the software, if they wish to receive the correction; document that the Alternative Working Solution will be used by the customers facility until the correction has been taken live. If you have any questions, contact (727) 789-0100.

Device

Device Recall SoftID.NET versions 2.0.0.6 2.0.0.19.
  • Model / Serial
    Versions: SoftID.NET 2.0.0.6 - 4/3/2007,  SoftID.NET 2.0.0.7 - 6/21/2007,  SoftID.NET 2.0.0.8 - 8/29/2007,  SoftID.NET 2.0.0.9 - 10/01/2007,  SoftID.NET 2.0.0.10 - 10/25/2007,  SoftID.NET 2.0.0.11 - 11/07/2007,  SoftID.NET 2.0.0.12 - 2/08/2008,  SoftID.NET 2.0.0.13 - 5/13/2008,  SoftID.NET 2.0.0.14 - 6/12/2008,  SoftID.NET 2.0.0.15 - 8/15/2008,  SoftID.NET 2.0.0.16 - 10/15/2008,  SoftID.NET 2.0.0.17 - 12/15/2008,  SoftID.NET 2.0.0.18 - 2/02/2009,  SoftID.NET 2.0.0.19 - 5/18/2009.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: AR, CA, FL, IL, IN, KS,LA, MA, MI, MN, MO, NC, ND,NH, NJ, NY, OH, PA, RI, TN, TX, VA and WI.
  • Product Description
    SoftID.NET versions 2.0.0.6 - 2.0.0.19. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || SoftID.NET is to be used in a medical or clinical laboratory setting by knowledgeable, trained, and experienced professionals. SoftID.NET supports bedside collection of patient specimens used in diagnostic testing. This product is integrated with Soft Computer's SoftLab, SoftScape and can also interface with all other SCC laboratory systems and Hospital Information Systems (HIS).
  • 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