Events

Retiro De Equipo (Recall) de SYST BRIGHTVIEW X WITH CRYSTAL 3/8"(UPGRADEABLE VERSON)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHILIPS ELECTRONICS LTD..

¿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
    73927
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-12-24
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Philips has become aware of several software issues which will be corrected with the release of a new software version. problem 1: when positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly by an operator causing an inappropriate rotation orbit calculation for the patient being imaged. when the acquisition was started and the detectors began to move into position the incorrect calculation resulted in the detectors coming in contact with the patient. problem 2: on separate occasions as the gantry system was moving to a relative 90 scan position of the detectors a patient or operator moved their hands or arms into the path of the detectors in the area of where the detectors meet resulting in the detectors coming in contact with the patient and operator. problem 3: while a user was manually positioning the patient for their exam and translating the pallet into the gantry bore the pallet catcher that supports the imaging table was higher than the imaging pallet resulting in a pinch point or table tilt if not engaged with the catcher. this problem can only occur on the brightview x or the brightview xct system.

Device

SYST BRIGHTVIEW X WITH CRYSTAL 3/8"(UPGRADEABLE VERSON)
  • Modelo / Serial
    Model Catalog: 453560829241 (Lot serial: ALL); Model Catalog: 2170-3002A (Lot serial: ALL); Model Catalog: 453560462131 (Lot serial: ALL); Model Catalog: 453560749161 (Lot serial: ALL); Model Catalog: 2170-3000A (Lot serial: ALL)
  • Descripción del producto
    SYST BRIGHTVIEW X WITH CRYSTAL 3/8" (UPGRADEABLE VERSION)
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    HC