Events

Retiro De Equipo (Recall) de Stryker Sonopet Console

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 Medtech K.K..

¿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
    14760
  • Fecha de inicio del evento
    2013-06-06
  • 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
    Stryker has received several reports that the irrigation pump was not functioning. in the case where the irrigation pump fails, saline would not be provided to the tip. as a result the cooling function would be lost and could potentially cause the tip to heat up potentially resulting in tissue burns to the patient.
  • Acción
    Product to be modified

Device

Stryker Sonopet Console
  • Modelo / Serial
    Model: Catalogue: 5450852000, Affected: Serial Numbers: 1134000114, 1134000124, 1134000134, 1134000144, 1134000184, 1134000204, 1209400174
  • Manufacturer
    Stryker Medtech K.K.

Manufacturer

Stryker Medtech K.K.
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA