Events

Retiro De Equipo (Recall) de Kidwalk I Dynamic Mobility 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 Prime Engineering.

¿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
    13485
  • Fecha de inicio del evento
    2012-10-01
  • 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: Permobil NZ Ltd, 181A McLeod Road, Waitakere City, Auckland 0650
  • Causa
    Following an incident in australia the manufacturer has updated the owner's manual (instructions for use) for the kidwalk with aluminium mast supplied prior to december 2012 to reinforce certain aspects, being;, - considerations on re-issue of the kidwalk, - regular inspection and annual service of the kidwalk, - the intended purpose of the kidwalk.
  • Acción
    Instructions for use to be updated

Device

Kidwalk I Dynamic Mobility System
  • Modelo / Serial
    Model: KW01, Affected: All serial numbers
  • Manufacturer
    Prime Engineering

Manufacturer

Prime Engineering