Events

Recall of XARIO 200 - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CANON MEDICAL SYSTEMS CANADA 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
    15267
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-24
  • 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
    A certain error message is displayed when a transducer is disconnected reconnected or another transducer is selected. if this error message is displayed and the system continues to be used the surface of the acoustic lens of the transducer may become hot which can result in mild burns if the transducer is used on one area of the body for a long time.

Device

XARIO 200 - MAIN UNIT

Manufacturer

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