Events

Recall of Masimo uSpO2 and HPLP Oximeter Cables

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Respironics 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
    18760
  • Event Initiated Date
    2015-06-29
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • 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, with the same oximetry cable, when a high spo2 value is measured, a low spo2 value would be displayed on the monitoring device.
  • Action
    Product to be returned to supplier

Device

Masimo uSpO2 and HPLP Oximeter Cables
  • Model / Serial
    Model: 1075383, Affected: All lots
  • Manufacturer
    Respironics Inc

Manufacturer

Respironics Inc
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA