Retiro De Equipo (Recall) de Magstim 90mm High Power Coil (used for diagnostic and therapeutic purposes by stimulating the cortical and peripheral nerves using the magnetic field)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtel Pty Ltd.

¿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
    RC-2013-RN-01014-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-03
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer, magstim has identified a manufacturing non-conformity on a single 9784-00, magstim 90mm high power coil. the nature of the non-conformance is the omission of the insulating sleeving that is normally applied over the two solder joints between the coil winding and the red and black conductors in the coil cable. although the coil passed the safety tests and functional checks, the non-conformance resulted in an increase in the risks associated with the use of the coil and could have led to complete failure of the coil during usage. the failure mode would be such that a loud bang would be produced and the coil would cease to function. there could also be damage to the stimulator to which the coil was connected.
  • Acción
    Medtel is requesting users to stop using the coils. Product can be returned to Medtel for replacement with unaffected stock.

Device

  • Modelo / Serial
    Magstim 90mm High Power Coil (used for diagnostic and therapeutic purposes by stimulating the cortical and peripheral nerves using the magnetic field)Part Number: 9784-00Serial Numbers: 2687, 2676ARTG Number: 136823
  • Manufacturer

Manufacturer

  • Source
    DHTGA