Events

Retiro De Equipo (Recall) de STIMPOD NMS 410

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por TELEFLEX MEDICAL 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
    132378
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-05-07
  • 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
    It has come to the manufacturer's attention that in isolated incidences the user continues to use the device if the keypad has been broken or is damaged. the damage to the keypad could possibly be caused by wear and tear the ingress of aggressive cleaning solutions or by abuse such as pressing the buttons with sharp objects like a pen tweezers or long finger nails. this could cause the internal circuitry of the keypad to become exposed which could potentially lead to an electric shock if the keypad and the electrodes are handled simultaneously. the occurrence of such phenomena is not a direct malfunction of the device but rather due to negligence.

Device

STIMPOD NMS 410
  • Modelo / Serial
    Model Catalog: XT-41001-NA (Lot serial: NA); Model Catalog: XT-45011-NA (Lot serial: NA)
  • Descripción del producto
    STIMPOD NMS410
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.