Retiro De Equipo (Recall) de ONDAL ACROBRAT 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
    66074
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-07-27
  • País del evento
  • 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
    Trumpf medical has been notified by its supplier that there is potential for fatigue fractures to develop in welds in the front joint of spring arms over time when subject to extreme forces. trumpf medical does not have complaints related to this failure mode. the supplier has advised that a visual inspection of the welded joints should be completed on a bi-annual basis (every two years) as advised in the user manual since july 2010. this inspection should therefore be occurring for all trumpf medical surgical light camera and monitor arm system spring arms.

Device

  • Modelo / Serial
    Model Catalog: 1528403 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 1513140 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 1400191 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 1441784 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 1558932 (Lot serial: > 10 lot numbers contact mfg)
  • Descripción del producto
    ONDAL ACROBRAT SPRING ARM
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    RICHMOND HILL
  • Empresa matriz del fabricante (2017)
  • Source
    HC