Events

Recall of QUBE COMPACT 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
    17967
  • Event Risk Class
    II
  • Event Initiated Date
    2012-10-24
  • 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
    Potential failure of the qube compact monitor where the input power can fail even though the power source at the wall has not been interrupted. the monitor automatically goes into battery mode and functions normally including the low battery alerts until the batteries become depleted and the monitor turns off. no one has been injured as a result of this issue. in addition there is the potential for the qube compact monitor to fail to turn on. no one had been injured as a result of this issue.

Device

QUBE COMPACT MONITOR
  • Model / Serial
    Model Catalog: 91390 (Lot serial: >10 lot numbers contact manf.)
  • Product Description
    Qube Compact Patient Monitor
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

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