Events

Recall of Olympus GF-UCT180 Ultrasonic Gastrovideoscope

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
    19165
  • Event Initiated Date
    2015-09-23
  • 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
    There is a risk of patient-to-patient infection if the device is not cleaned appropriately., key changes in the new instruction for use are highlighted below:, * inclusion of instruction on how to attach the cleaning adapter (maj-350) to the instrument channel port of the gf-uct180, * the balloon applicator (maj-675) and the cleaning brush (maj-1534) are to be reprocessed for reuse. the maj-675 and maj-1534 are to be reprocessed in accordance with the cleaning, disinfection, and sterilisation procedures for reusable parts and reprocessing equipment.
  • Action
    Instructions for use to be updated

Device

Olympus GF-UCT180 Ultrasonic Gastrovideoscope

Manufacturer

Olympus Medical Systems Corporation