Events

Recall of SOFTPATH GUI 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
    47693
  • Event Risk Class
    II
  • Event Initiated Date
    2014-12-24
  • 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
    In very specific scenarios modifications to the diagnostic text may be saved to the database but do not appear on the report sent to the physician or documented on the report but not saved in the database.

Device

SOFTPATH GUI SOFTWARE
  • Model / Serial
    Model Catalog: V.4.3.0.12 (Lot serial: N/A); Model Catalog: V.4.3.0.15 (Lot serial: N/A); Model Catalog: V.4.3.0.14 (Lot serial: N/A); Model Catalog: V.4.4.0.1 (Lot serial: N/A)
  • Product Description
    SoftPath GUI Software
  • Manufacturer
    SCC SOFT COMPUTER

Manufacturer

SCC SOFT COMPUTER