Events

Recall of MASIMO SET RAD 5V PULSE OXIMETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH 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
    18289
  • Event Risk Class
    II
  • Event Initiated Date
    2004-02-24
  • 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
    Source medical conducted a recall on units sold in canada because they are not yet licenced.

Device

MASIMO SET RAD 5V PULSE OXIMETER
  • Model / Serial
    Model Catalog: 1705 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: MAS1705 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 1802 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: MAS1802 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    RAD-5V HANDHELD PULSE OXIMETER
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC