Events

Recall of Masimo uSpO2 and HPLP Oximetry Cables

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-00542-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-06-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00542-1
  • 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
    A small number of oximetry cables have been identified with crossed-internal wires.The effect on performance when these wires are crossed is that when a low spo2 value is measured, a high spo2 value would be displayed on the monitoring device. additionally, in the same oximetry cable, when a high spo2 value is measured, a low spo2 value would be displayed on the monitoring device.
  • Action
    Philips is providing instructions for hospitals to verify the performance of the oximetry cables. If the cables are not working as expected they are to be returned to Philips for replacement or refund. This action has been closed-out on 06/09/2016.

Device

Masimo uSpO2 and HPLP Oximetry Cables

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA