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
    39341
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-11-07
  • 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
    Several software issues which will be corrected with the release of a new software version. 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. this affects only the brightview xtc systems. 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 degee position. however in the middle of a clinical scan acquisition the detector heads moved away from the patient (centre of rotation) in an uncommanded motion and subsequently the gantry unexpectedly rotated to the 240 degree position. the movement from 90 degrees to the 240 degrees may take approximately 7 seconds. 3-at the completion of a thyroid procedure the operator executed the pinhole pre-programmed motion (ppm) and noticed a change in the sequence of motions between the imaging pallet and the detector radius. the system moved the patient pallet from the gantry before the detector installed with the pinhole collimator was moved out of the path of the patient. this sequence of motions differed from the previous software release. this affects systems with software version 1.2.3/2.5.3.

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: 2170-3000A (Lot serial: ALL); Model Catalog: 453560749161 (Lot serial: ALL); Model Catalog: 453560462131 (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