Events

Recall of Softbank II 23.1.2.8 25.3.0.0

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Soft Computer Consultants, Inc..

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
    76046
  • Event Risk Class
    Class 2
  • Event Number
    Z-1097-2017
  • Event Initiated Date
    2016-10-06
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152048
  • 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, transmission and storage, patient data - Product Code NSX
  • Reason
    Software error. potential for incorrect results.
  • Action
    Consignees were sent a recall notification, dated 10/06/2016, providing instructions for software correction. The firm indicates that the issue will be resolved with a mandatory hot fix. Hot fix will be released when its effectiveness is confirmed. Consignees are instructed to acknowledge receipt of the recall notification and grant permission for the recalling firm to load the hot fix when available. The firm can be contacted by calling Technical Support at 1-800-763-8522. Until the hot fix is available, consignees can still operate the software by exiting (Esc-Quit) the Test Verify option after each save changes (F12-Accept).

Device

Softbank II 23.1.2.8 25.3.0.0
  • Model / Serial
    Version: 23.1.2, 23.2.0, 25.0.0, 25.1.0, 25.2.0, 25.3.0
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica
  • Product Description
    SCC Soft Computer Softbank II software || Product Usage: || Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.
  • Manufacturer
    Soft Computer Consultants, Inc.

Manufacturer

Soft Computer Consultants, Inc.
  • Manufacturer Address
    Soft Computer Consultants, Inc., 5400 Tech Data Dr, Clearwater FL 33760-3116
  • Manufacturer Parent Company (2017)
    Soft Computer Consultants Inc.
  • Source
    USFDA