Events

Retiro De Equipo (Recall) de HELION S EXAM LIGHT (PART: ONDAL ACROBAT SWING SPRING ARM)

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

¿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
    26958
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-02-27
  • 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
    After an average seven years of use fatigue breaks at the plastic joint may occur. the likelihood of breaks increases with the frequency of moving the spring arm to its upper limit. a swing arm may rupture while in use or while in the inoperative position. if the joint breaks the swing arm falls down abruptly and without interruption. description of the product:helion s exam lights may be on mobile stands mounted from the ceiling or mounted from an equipment boom. typical locations for these lights are intensive care units and emergency departments exam rooms. swing arms were manufactured with either a white plastic joint or a metal joint. product with the metal joint is not affected by this recall.

Device

HELION S EXAM LIGHT (PART: ONDAL ACROBAT SWING SPRING ARM)
  • Modelo / Serial
    Model Catalog: H300 (Lot serial: > 10 lot numbers contact mfg)
  • Descripción del producto
    Helion S Exam Light (part: Ondal Acrobatr Swing Spring Arm)
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.
  • Dirección del fabricante
    RICHMOND HILL
  • Empresa matriz del fabricante (2017)
    Olympus Corporation
  • Source
    HC