Events

Recall of Masimo Rad-8 Pulse Oximeters Manufactured from March 27, 2009 to January 24, 2013

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Masimo Australia Pty Ltd.

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
    RC-2013-RN-00379-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00379-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Masimo has identified a very small number of rad-8 devices that, 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.This recall action was not notified to the tga before it was initiated by masimo australia.
  • Action
    Masimo is providing two options to the customers for correction and removal. The first option is to return the Rad-8 devices for Masimo for repair. The second option is for a biomedical engineer employed by a customer to repair the device in the field once qualified by Masimo to do so. This action has been closed-out on 11/02/2016.

Device

Masimo Rad-8 Pulse Oximeters Manufactured from March 27, 2009 to January 24, 2013
  • Model / Serial
    Masimo Rad-8 Pulse Oximeters Manufactured from March 27, 2009 to January 24, 2013Device Identifiers: 1844, 1959, 1961, 1963, 22042, 22595, 3446, 9019, 9049, 9073, 9165, 9174, 9190, 9212, 9224,1845, 1960, 1962, 1964, 9020, 9050, 9074, 9166, 9175, 9191, 9213, 9192, 9194, 9193, 9195ARTG Number: 138873
  • Manufacturer
    Masimo Australia Pty Ltd

Manufacturer

Masimo Australia Pty Ltd