Events

Retiro De Equipo (Recall) de Philips BrightView SPECT/CT Combination

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
    20280
  • Fecha de inicio del evento
    2016-06-16
  • 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
    During a non-auto body contouring (abc), non-circular, rel-180 scan, the detector may come in contact with the patient. if this occurs, contact sensors would pause the scan., the manufacturer has released a revised letter( 26/08/2016) which includes further detail specific to software version to the problem description, how to identify affected products, and advice on actions for customer clarity.
  • Acción
    Software to be upgraded

Device

Philips BrightView SPECT/CT Combination

Manufacturer

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