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
  • ID del evento
  • Clase de Riesgo del Evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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. issue 1: during a cardiac non-auto body contouring (abc) scan using cardiac high resolution (chr) collimators the collimator may come in contact with the bottom edge of the patient pallet. if this occurs collision sensors would pause the scan. scan interruption may lead to the need for rescan or reinjection of radiopharmaceuticals. issue 2: during a scan the gantry motion may halt prematurely. this causes the scan sequence to pause. incidences of scan sequence pause have been reported to occur more often after installation of the following software: - version 1.2.4 for brightview. - version 2.5.4 for brightview x and brightview xct. issue 3: the operator will receive a warning message indicating that the scan may not complete when defined with the following scan parameters:-detector relative angle: 90 and head first supine or feet first prone this message further instructs the operator to re-mark the points used to define the orbit. issue 4: -the resolved defects section of the user release document 1.2.4/2.5.4 for brightview brightview x and brightview xct (45980022532 rev a) listed two pre-programmed motions (ppms) whose motion sequences were changed by the release of software version 1.2.4/ 2.5.4. the software has been updated so that the patient table is extracted before detectors are in motion. in addition to the two ppms in the user release document the following 31 ppms have also changed motion sequence: -dh hands left - dh hands right - dh sitting - dh standing - install head holder* - remove head holder* - anterior oblique 30 - posterior oblique 30 - anterior oblique 60 - posterior oblique 60 - anterior oblique 45 - posterior oblique 45 - seated plantar - sh posterior det 1 - sh posterior det 2 - planar - pallet change - outerroom det 1 left - outerroom det 1 right - outerroom det 2 left - outerroom det 2 right - bed imaging - rel 90 test spin** rel 180 test spin** -pinhole*** - pinhole anterior* pinhole posterior* - lung -pallet in - lung -rotate cw 45? - lung -rotate ccw 45 - lung -pallet out - applicable only to brightview x and brightview xct applicable only to brightview xct - applicable only to brightview.


  • Modelo / Serial
    Model Catalog: 453560749161 (Lot serial: >10 contact mfg.); Model Catalog: 453560462131 (Lot serial: >10 contact mfg.); Model Catalog: 2170-3000A (Lot serial: >10 contact mfg.); Model Catalog: 453560829241 (Lot serial: >10 contact mfg.); Model Catalog: 2170-3002A (Lot serial: >10 contact mfg.)
  • Descripción del producto
  • Manufacturer


  • Dirección del fabricante
  • Empresa matriz del fabricante (2017)
  • Source