Events

Retiro De Equipo (Recall) de MOSAIQ with Locate

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 Impac Medical Systems Inc.

¿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
    20410
  • Fecha de inicio del evento
    2016-07-19
  • 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: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • Causa
    It is possible that a change to an order set will not be saved in the current, open care plan when the following workflow is utilized:, 1. open either the care plan edit form or the care plan instance form and leave the form open., 2. select an order set that is part of the same care plan and make a change to the order set. this can be a change to the order set name or label or a change to the drug, dose, administration instructions, etc., 3. the update made to the order set will not be saved in the current, open care plan.
  • Acción
    Software to be upgraded

Device

MOSAIQ with Locate

Manufacturer

Impac Medical Systems Inc
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    NZMMDSA