Events

Retiro De Equipo (Recall) de RIWO NET MOBILE SYSTEM TROLLEY

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

¿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
    131770
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-05-02
  • 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
    In one single case so far the vesa mounting plate broke at it's mounting point while the user was adjusting the inclination (tilt). internal investigations have shown that as a results of a manufacturing error the weld of the mounting plate at the mounting point of the rotary joint was faulty. there is therefore a risk of a monitor fastened to the vesa mounting plate failling down when the tilt is adjusted. the vesa mounting plate is part of the device riwo net mobile system trolley.

Device

RIWO NET MOBILE SYSTEM TROLLEY
  • Modelo / Serial
    Model Catalog: PART #64330914 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: PART #321114453 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: PART #321114452 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: CATALOG #32115.011 (Lot serial: ALL SERIAL NUMBERS)
  • Descripción del producto
    RIWO NET MOBILE SYSTEM TROLLEY
  • Manufacturer
    RICHARD WOLF GMBH

Manufacturer

RICHARD WOLF GMBH