Events

Recall of Device Recall SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports.

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
    56872
  • Event Risk Class
    Class 2
  • Event Number
    Z-0362-2011
  • Event Initiated Date
    2010-06-22
  • Event Date Posted
    2010-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94757
  • 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
    Software, blood bank, stand alone products - Product Code MMH
  • Reason
    Scc soft computer is issuing a correction for softbank ii versions: 23.1.2.X, 23.2.0.X, and 25.0.0.X software applications. functionality issue - for clients generating patient history reports using patient>reports>batch reports>history report option in softbank with softreports activated for patient reports, when the report is generated for more than one patient all of the results for the qualif.
  • Action
    SCC Soft Computer notified Customers on June 22, 2010, via the proprietary communication software entitled "Risk-to-Health Notification Task Verbiage" dated June 11, 2010. The notification described the product, problem and action to be taken by customer. The customers were instructed to acknowledge receipt of the notification; to grant permission to load the required hot fix, and to make the manual correction. For the manual correction to the datapath for patient report layouts, your SoftBank Support Specialist will Coordinate those changes and your validation of affected environments. If you have any questions, contact (727) 789-0100.

Device

Device Recall SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports.
  • Model / Serial
    Versions 23.1.2.x, 23.2.0.x, 25.0.0.x
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: U.S. and country of Canada.
  • Product Description
    SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || 23.1:BK040048 || 23.2:BK080020 || 25.0:BK090017 || The SoftBank II application, using SoftScape user interface, is a decision support software device that requires knowledgeable user intervention to document steps and events in a transfusion service. The application provides single and multiple site facilities the ability to manage their transfusion service by integrating patient and unit information. SoftBank uses an SCC proprietary interface called SoftScape that facilitates access to the application.
  • 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