Events

Retiro De Equipo (Recall) de Stryker Neptune 2 Rover Surgical fluid/smoke waste management system

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Stryker Instruments.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    18723
  • Fecha de inicio del evento
    2015-07-06
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Recalling Organisation: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    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.
  • Acción
    Product to be modified

Device

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

Manufacturer

Stryker Instruments
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA