Events

Retiro De Equipo (Recall) de OMNIDIAGNOST ELEVA

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
    75334
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-08-18
  • 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 healthcare has discovered through customer feedback a system restart failure as a result of a blown fuse. the fuse was blown due to an unexpected main power failure in the hospital in which the uninterruptible power supply (ups) took over. philips discovered after internal investigation that in time the fuse degrades. the degrading depends on the initial value of the fuse the current through the fuse a continuous high operating temperature the environmental temperature and the time the system is operational. after degradation the blowing of the fuse may be triggered by an unexpected main power failure as described above.

Device

OMNIDIAGNOST ELEVA
  • Modelo / Serial
    Model Catalog: 708027 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 000454 (Lot serial: 33); Model Catalog: 000454 (Lot serial: 146); Model Catalog: ALLURA XPER FD20/20 (Lot serial: 171); Model Catalog: ALLURA XPER FD20 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 0708MD02 (Lot serial: > 10 numbers contact mfg.); Model Catalog: ALLURA XPER FD20/20 (Lot serial: 607); Model Catalog: ALLURA XPER FD10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: ALLURA XPER FD20/10 (Lot serial: 168); Model Catalog: ALLURA XPER FD20/10 (Lot serial: 37); Model Catalog: ALLURA XPER FD20/10 (Lot serial: 57); Model Catalog: ALLURA XPER FD20/10 (Lot serial: 567); Model Catalog: ALLURA XPER FD20/10 (Lot serial: 52); Model Catalog: ALLURA XPER FD20/10 (Lot serial: 283); Model Catalog: ALLURA XPER FD10/10 (Lot serial: 154); Model Catalog: ALLURA XPER FD10/10 (Lot serial: 307); Model Catalog: ALLURA XPER FD10/10 (Lot serial: 40); Model Catalog: ALLURA XPER FD10/10 (Lot serial: 306); Model Catalog: ALLURA XP
  • Descripción del producto
    OMNIDIAGNOST ELEVA;ALLURA XPER FD20 OR TABLE;ALLURA XPER FD20/20;ALLURA XPER FD20 SYSTEM - MAIN UNIT;MULTIDIAGNOST ELEVA - FLAT DETECTOR - IMAGE DETECTOR;ALLURA XPER FD10;MULTIDIAGNOST ELEVA - IMAGE INTENSIFIER - TV IMAGE DETECTOR;ALLURA XPER FD20/10 SYST
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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