Events

Recall of Natus - Phototherapy unit

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

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
    21478
  • Event Initiated Date
    2017-06-13
  • 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: Paragon Medical Ltd t/a LR Instruments and Scanmedics, c/o MediRay, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Reason
    The manufacturer is replacing all the earlier generation neoblue 2 lights which will eliminate the possibility that a neoblue light may have a replacement board installed which allows it to be used at a higher overall light intensity than the devices were originally cleared to deliver.
  • Action
    Product to be exchanged

Device

Natus - Phototherapy unit

Manufacturer

Natus Medical Incorporated