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
    17772
  • Fecha de inicio del evento
    2014-11-28
  • 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 reports there are 2 issues to be addressed:, 1/ following a cardiac scan and when using smartstep* to setup the camera for a relative 180 procedure, it is possible for detector 1 to collide with the head holder when moving from the position at which the flat panel is deployed., 2/ during a patient spect lung acquisition, the clinical scan acquisition protocol commanded the gantry rotation to move from the 45 degree to the 90 degree position. however, in the middle of a clinical scan acquisition, the detector heads moved away from the patient (center of rotation) in an uncommanded motion and subsequently the gantry unexpectedly rotated to the 240 degree position. the movement from 90 degree to the 240 degree may take approximately 7 seconds.
  • Acción
    Software to be upgraded

Device

Philips Brightview SPECT/CT Combination

Manufacturer

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