Events

Recall of BEDSIDE MONITOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SPACELABS HEALTHCARE (CANADA) 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
    146226
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-27
  • 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
    Spacelabs healthcare learned through internal testing that the power supply attachment screw may damage an internal component and causes the monitor to not turn on not turn off or involuntarily shut down. the screw used to attach the power supply to the monitor may come into contact with a capacitor on the internal power supply pcba causing the capacitor to crack and the monitor to fail.

Device

BEDSIDE MONITOR
  • Model / Serial
    Model Catalog: 91393 (Lot serial: > 10 numbers contact manf.)
  • Product Description
    XPREZZON Bedside Monitor
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

SPACELABS HEALTHCARE (CANADA) INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    HC