Events

Recall of RAD-8 HORIZONTAL MASIMO

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CANADIAN HOME HEALTHCARE 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
    50980
  • Event Risk Class
    II
  • Event Initiated Date
    2013-05-13
  • 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
    Some rad-8 devices when moved can power off without the operator pressing the power button.If a change in power status goes unnoticed by the caretaker a delay of care could result.

Device

RAD-8 HORIZONTAL MASIMO
  • Model / Serial
    Model Catalog: 1959 (Lot serial: M42372); Model Catalog: 9190 (Lot serial: M42372); Model Catalog: 9224 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 9212 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 9174 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 9165 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 9073 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 9049 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 9019 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 3446 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 22595 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 22042 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 1963 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 1961 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 1844 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 1959 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 9190 (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 9224 (Lot serial: M423
  • Product Description
    Rad-8 Pulse Oximeter
  • Manufacturer
    CANADIAN HOME HEALTHCARE INC.

Manufacturer

CANADIAN HOME HEALTHCARE INC.
  • Manufacturer Address
    OAKVILLE
  • Source
    HC