Events

Rappel de Olympus GF-UCT180 Ultrasonic Gastrovideoscope

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Olympus Medical Systems Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    19165
  • Date de mise en oeuvre de l'événement
    2015-09-23
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Olympus (NZ) Ltd, 15D Paul Matthews Road, Albany, Auckland
  • Cause
    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