Events

Recall of Measurement Modules

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Philips Medizinsysteme Boblingen GmbH.

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
    21944
  • Event Initiated Date
    2017-09-07
  • 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
    The manufacturer has recently discovered that when performing 12-lead ecg monitoring, if an affected monitor detects and alerts the user that the ecg lead set is damaged or otherwise not performing appropriately, it will apply corrective filtering that can distort the st-segment, which could contribute to a misdiagnosis or a misinterpretation causing a delayed or even an incorrect treatment if relied on by the user.

Device

Measurement Modules

Manufacturer

Philips Medizinsysteme Boblingen GmbH
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA