Events

Retiro De Equipo (Recall) de Philips BrightView XCT Imaging 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 Philips Radiation Oncology Systems.

¿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
    15353
  • Fecha de inicio del evento
    2013-09-16
  • 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
    Philips received a report from the field that the fpd failed to remain securely latched in the stowed position., a system warning message appeared warning the user that the fpd was unlatched. by design, the unlatching of the fpd caused the system to activate the e-stop. in an attempt by the operator to clear the warning message while in the 0 degree position, the fpd released from the stowed position.
  • Acción
    Product to be modified

Device

Philips BrightView XCT Imaging System

Manufacturer

Philips Radiation Oncology Systems
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA