Events

Recall of Masimo Rad-8 Pulse Oximeters

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Masimo Corporation.

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
    14582
  • Event Initiated Date
    2013-05-02
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Promed Technologies Ltd, Unit B, 14-22 Triton Drive, Upper Harbour, North Shore, Auckland 0632
  • Reason
    Manufacturer 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 then a delay of care could result.
  • Action
    Product to be modified

Device

Masimo Rad-8 Pulse Oximeters
  • Model / Serial
    Model: Manufactured from March 27 2009 until Jan 24 2013, Affected:
  • Manufacturer
    Masimo Corporation

Manufacturer

Masimo Corporation