Events

Retiro De Equipo (Recall) de Philips BrightView XCT 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
    17728
  • Fecha de inicio del evento
    2014-11-21
  • 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 while performing a clinical spect/ ct study on a brightview xct spect/ct systems, the ct portion of the scan was interrupted (stopping the ct exposure at the time of interruption) and did not complete successfully., interruption of the ct acquisition portion of the scan may necessitate a rescan of the interrupted segment, resulting in overall radiation to the patient being higher than planned. the additional radiation would be less than the amount delivered from a successful scan of that segment.
  • Acción
    Product to be modified

Device

Philips BrightView XCT System

Manufacturer

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