Events

Recall of HF-buttons, needles (Germany)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Olympus Winter & Ibe 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
    21721
  • Event Initiated Date
    2017-07-25
  • 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 ifu has been updated to include new contraindications, warnings and safety information. the contraindications information have been added as a part of the fda guidance for "hysteroscopes and gynaecologic laparoscopes submission guidance for 510k". the warnings and safety information have been added as a result of an update to the iec 60601-1 3rd edition, standard requirements.
  • Action
    Instructions for use to be updated

Device

HF-buttons, needles (Germany)

Manufacturer

Olympus Winter & Ibe GmbH