Events

Retiro De Equipo (Recall) de ALLURA XPER FD10/10 - MAIN UNIT

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
    143084
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-12-28
  • 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 that extra monitors so called 7th or 8th monitor mounted on the monitor ceiling suspension (mcs) might disengage from the mcs and fall down. the two small set screws securing the two gliding rods into an aluminum block of the support arm can come loose because of vibrations and forces exerted on them. if the set screws have come loose gravity can keep the rods in position. however if a force is exerted on the monitor pushing it forward the monitor can topple forward. once the monitor has toppled over it is only attached with its wires. if the monitor breaks loose of its wires it will drop on the floor. see e-file for french translation.

Device

ALLURA XPER FD10/10 - MAIN UNIT
  • Modelo / Serial
    Model Catalog: ALLURA XPER FD10/10 (Lot serial: N/A); Model Catalog: ALLURA XPER FD20/10 (Lot serial: N/A); Model Catalog: ALLURA XPER FD20/20 (Lot serial: N/A); Model Catalog: ALLURA XPER FD10 (Lot serial: N/A); Model Catalog: ALLURA XPER FD20 (Lot serial: N/A); Model Catalog: 000454 (Lot serial: N/A)
  • Descripción del producto
    ALLURA XPER FD10/10 - MAIN UNIT;ALLURA XPER FD20/10 SYSTEM-MAIN UNIT;ALLURA XPER FD20/20;ALLURA XPER FD10;ALLURA XPER FD20 SYSTEM - MAIN UNIT;ALLURA XPER FD20 OR TABLE
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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