Events

Retiro De Equipo (Recall) de BRILLIANCE CT BIG BORE SYSTEM - 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
    71318
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-10-13
  • 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
    The patient support table top may fail to move in the horizontal direction when it is commanded to do so during ct scans due to a potential mechanical linkage failure. the system cannot automatically detect this failure to abort the scan or to alert the user. of the 5000 ct systems potentially affected there have been 2 occurrences of this failure mode in the past 10 years.

Device

BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: 4535 670 88051 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 4550 110 09021 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 4550 110 04011 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 728311 (Lot serial: 200071); Model Catalog: 453567005721 (Lot serial: 6149); Model Catalog: 453567005721 (Lot serial: 6150); Model Catalog: 728306 (Lot serial: 100195); Model Catalog: 728306 (Lot serial: 100223); Model Catalog: 4535 670 78851 (Lot serial: 6352); Model Catalog: 728306 (Lot serial: 100206); Model Catalog: 728306 (Lot serial: 100249); Model Catalog: 728306 (Lot serial: 100101); Model Catalog: 728306 (Lot serial: 100290); Model Catalog: 728306 (Lot serial: 100046); Model Catalog: 728306 (Lot serial: 100440); Model Catalog: 728326 (Lot serial: 30003); Model Catalog: 728326 (Lot serial: 30004); Model Catalog: 728323 (Lot serial: 30004); Model Catalog: 728323 (Lot serial: 320148); Model Catalog: 728326 (Lot serial: 320148); Model Catalog: 728323 (Lot serial: 320123); Model C
  • Descripción del producto
    BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT;BRILLIANCE 40/64 SLICE CT SYSTEM;BRILLIANCE ICT SP SYSTEM - MAIN;BRILLIANCE CT SYSTEM (16P);BRILLIANCE ICT SYSTEM - SYSTEM;BRILLIANCE 6/10/16 SLICE CT SYSTEM;INGENUITY CT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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