Events

Retiro De Equipo (Recall) de MODEL 860 TRANSCUTANEOUS CO2/O2 MONITOR SYSTEM - MONITOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por RESPIRONICS CALIFORNIA LLC.

¿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
    66207
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-12-11
  • 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
    Certain types of electri-cord manufacturing company power cords used with medical devices may be defective as the power cords prongs may crack and fail at or inside the plug. the issue affects medical device ac power cords equipped with a plug that has a prong and ground-pin insert design and a black plastic bridge connecting the terminal prongs on the plug ("tall bridge" design). medical device power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected.

Device

MODEL 860 TRANSCUTANEOUS CO2/O2 MONITOR SYSTEM - MONITOR
  • Modelo / Serial
    Model Catalog: U6590-00 (Lot serial: 1432); Model Catalog: 6590-00 (Lot serial: 1432); Model Catalog: U6590-00 (Lot serial: 1392); Model Catalog: 6590-00 (Lot serial: 1392); Model Catalog: U6590-00 (Lot serial: 1594); Model Catalog: 6590-00 (Lot serial: 1594); Model Catalog: 5758-00 (Lot serial: 5904); Model Catalog: 5758-00 (Lot serial: 4824); Model Catalog: 5758-00 (Lot serial: 5629); Model Catalog: 5758-00 (Lot serial: 4859); Model Catalog: 5758-00 (Lot serial: 4728); Model Catalog: 5758-00 (Lot serial: 4723); Model Catalog: 5758-00 (Lot serial: 6213); Model Catalog: 5758-00 (Lot serial: 5436); Model Catalog: U6590-00 (Lot serial: 1579); Model Catalog: 6590-00 (Lot serial: 1579); Model Catalog: U6590-00 (Lot serial: 2129); Model Catalog: 6590-00 (Lot serial: 2129); Model Catalog: U6590-00 (Lot serial: 1509); Model Catalog: 6590-00 (Lot serial: 1509); Model Catalog: U6590-00 (Lot serial: 1472); Model Catalog: 6590-00 (Lot serial: 1472); Model Catalog: U6590-00 (Lot serial: 1455); Model Catalog: 6590-00 (Lo
  • Descripción del producto
    MODEL 860 TRANSCUTANEOUS CO2/O2 MONITOR SYSTEM
  • Manufacturer
    RESPIRONICS CALIFORNIA LLC

Manufacturer

RESPIRONICS CALIFORNIA LLC
  • Dirección del fabricante
    CARLSBAD
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    HC