Events

Recall of Olympus UHI-4 High Flow Insufflator Unit

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

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
    17112
  • Event Initiated Date
    2014-08-04
  • 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: Olympus (NZ) Ltd, 15D Paul Matthews Road, Albany, Auckland
  • Reason
    The power switch of the above mentioned models may become stuck after extended use and the following may occur:, 1) when the power switch is stuck whilst the unit is on, the unit cannot be turned off using the power switch on the model., 2) when the power switch is stuck whilst the unit is off, the unit cannot be turned on using the power switch on the unit.
  • Action
    Product to be modified

Device

Olympus UHI-4 High Flow Insufflator Unit

Manufacturer

Olympus Medical Systems Corporation