Events

Retiro De Equipo (Recall) de Philips MultiDiagnost Eleva

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 Philips Medical Systems Nederland BV.

¿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
    22831
  • Fecha de inicio del evento
    2018-04-18
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Causa
    The manufacturer has become aware that the fixation of the upper and lower tilt actuator of the md-eleva system might break off and the table will start to rotate from 0 to + 90 / - 90 degrees with high speed if the point of gravity of the table is beyond its rotation point. this rotating movement can not be stopped by the user, which potentially could lead to the patient falling off the table.
  • Acción
    Product to be modified

Device

Philips MultiDiagnost Eleva
  • Modelo / Serial
    Model: MultiDiagnost Eleva 708032, MultiDiagnost Eleva with Flat Detector 708034, MultiDiagnost Eleva with Flat Detector 708038, Affected:
  • Manufacturer
    Philips Medical Systems Nederland BV

Manufacturer

Philips Medical Systems Nederland BV
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA