Events

Recall of Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet. (used with pulse oximeter for the measurement of parameters such as arterial oxygen).

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-2015-RN-01074-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01074-1
  • 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 specific lots of sensors that were manufactured with incompatible configurations. this could result in sensors that will either not provide readings for the spco and spmet parameters or inaccurate readings. the specific behaviour will depend on the firmware version of the technology board in the device. spco measurements, when displayed, could be incorrectly elevated throughout the measurement range. spmet measurements above 6% could be affected by a negative bias of 1.5%, on average.
  • Action
    Masimo is advising users to inspect stock and quarantine any affected units for replacement with unaffected stock. This action has been closed-out on 18/08/2016.

Device

Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet. (used with pulse oxi...
  • Model / Serial
    Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet. (used with pulse oximeter for the measurement of parameters such as arterial oxygen). Reference: 2696 Lot Number: 15HA6Sensor Reference: 24087-A15G760 , 24087-A15H754ARTG Number: 157503
  • Manufacturer
    Masimo Australia Pty Ltd

Manufacturer

Masimo Australia Pty Ltd