Events

Recall of SOFTBANK II SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada 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
    62306
  • Event Risk Class
    II
  • Event Initiated Date
    2011-10-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    When printing an isbt label for blood product with an expiration time of midnight (00:00) the generated label prints 23:59 instead as the expiration time in the barcode. the unit can be mislabeled with a falsely extended expiration time.

Device

SOFTBANK II SOFTWARE
  • Model / Serial
    Model Catalog: V.25.1 (Lot serial: ALL LOT); Model Catalog: V.23.2 (Lot serial: ALL LOT); Model Catalog: V.25.0 (Lot serial: ALL LOT)
  • Product Description
    SOFTBANK II V.23.2/25.0/25.1
  • Manufacturer
    SCC SOFT COMPUTER

Manufacturer

SCC SOFT COMPUTER