Events

Retiro De Equipo (Recall) de Pentax Ultrasound Video Bronchoscope

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Pentax Medical Pte 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-2017-RN-00908-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-02
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00908-1
  • 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
    Pentax medical has become aware of an error in the description of the instructions for use (ifu) for a specific model of pentax ultrasound video bronchoscope relating to the reprocessing of scopes. following the instructions in the erroneous ifu may result in ineffective reprocessing which may pose a risk of contamination and/or anaphylactic shock.
  • Acción
    Pentax Medical is requesting customers ensure that all potential users in affected facilities are made aware of this recall action and are provided with the new Instructions For Use (IFU) supplied with the Customer Letter.

Device

Pentax Ultrasound Video Bronchoscope
  • Modelo / Serial
    Pentax Ultrasound Video BronchoscopeModel Number: EB-1970UKAll Serial NumbersARTG Number: 234953
  • Manufacturer
    Pentax Medical Pte Ltd

Manufacturer

Pentax Medical Pte Ltd
  • Source
    DHTGA