Events

Rappel de Stryker Neptune 2 Rover Surgical fluid/smoke waste management system

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 Stryker Instruments.

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
    18723
  • Date de mise en oeuvre de l'événement
    2015-07-06
  • 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: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Cause
    It has been identified during the installation of neptune rovers, there is a potential for the rover's diverter valve assembly to not actuate during docking, preventing the cleaning cycle from occurring and inhibiting prefill water from being supplied to the neptune fresh water system. the diverter valve's material combined with the heat-treating process has the potential to cause diverter valve corrosion when the rover is allowed to sit for a period of greater than 40 days., only neptune 2 rovers out of use for greater than 40 days have the potential of exhibiting the failure. neptune 2 rovers that have been used within the past 40 days are not likely to experience any issue.
  • Action
    Product to be modified

Device

Stryker Neptune 2 Rover Surgical fluid/smoke waste management system
  • Modèle / numéro de série
    Model: 0702-002-000, Affected: Serial Numbers ranging from 0803118093 through 1505400223
  • Manufacturer
    Stryker Instruments

Manufacturer

Stryker Instruments
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    NZMMDSA