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
    86863
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-12
  • 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 issue with qube compact monitors that are "docking station ready" - that have had a port cover plate removed allowing the monitor to be used with the optional qube docking station. if a docking station ready qube monitor is powered up undocked connected to the network via an ethernet hardwire connection and then disconnected from the ethernet hardwire connection and inserted into a qube docking station a switch condition will cause the monitor to lose the network connection. all bedside alarms will continue to function normally. no one has been injured as a result of this issue.

Device

QUBE COMPACT MONITOR

Manufacturer

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