Events

Recall of APLIO ARTIDA - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TOSHIBA CANADA MEDICAL SYSTEMS LIMITED.

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
    100633
  • Event Risk Class
    II
  • Event Initiated Date
    2010-08-16
  • 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 artida ultrasound systems model ssh-880cv there are two issues noted regarding (1) some measurement values are displayed incorrectly on the report page and (2) temperature-related warnings are not consistently displayed.

Device

APLIO ARTIDA - MAIN UNIT
  • Model / Serial
    Model Catalog: SSH-880CV (Lot serial: S/N: W1F0982235); Model Catalog: SSH-880CV (Lot serial: S/N: WIF0982239); Model Catalog: SSH-880CV (Lot serial: S/N: WIF0982240); Model Catalog: SSH-880CV (Lot serial: S/N: W1F0982231); Model Catalog: SSH-880CV (Lot serial: S/N: W1F0982232); Model Catalog: SSH-880CV (Lot serial: S/N: W1F0982233); Model Catalog: SSH-880CV (Lot serial: S/N: W1B0862082); Model Catalog: SSH-880CV (Lot serial: S/N: w1F0982234)
  • Product Description
    APLIO ARTIDA
  • Manufacturer
    TOSHIBA CANADA MEDICAL SYSTEMS LIMITED

Manufacturer

TOSHIBA CANADA MEDICAL SYSTEMS LIMITED
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    HC