Events

Retiro De Equipo (Recall) de ITD VESA 75/100 Adaptation with Rotation (Articulating Arm on Endoscope Trolley)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Karl Storz Endoscopy Australia 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-2016-RN-00200-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-23
  • 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-2016-RN-00200-1
  • 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
    A manufacturing defect has been detected which could lead to the loosening of the rivets of the interface plate that connects the monitor and touch screen to the articulating arms on the trolley (vesa 75/ 100 adaptation with rotation). the riveting of the rotation may not have been carried out according to the manufacturer's specifications.In rare cases, it can lead to a loosening of the connection plate and result in injuries to patients and/or users.
  • Acción
    KARL STORZ is advising customers that they can opt for their own engineers to replace the adaptor plates or nominate KARL STORZ to replace the affected component on site.

Device

ITD VESA 75/100 Adaptation with Rotation (Articulating Arm on Endoscope Trolley)
  • Modelo / Serial
    ITD VESA 75/100 Adaptation with Rotation (Articulating Arm on Endoscope Trolley)Lot Numbers: HA.2200.902 and HA.2237.902Multiple Serial Numbers affectedManufactured between 1 June - 26 November 2015.ARTG Number: 168578
  • Manufacturer
    Karl Storz Endoscopy Australia Pty Ltd

Manufacturer

Karl Storz Endoscopy Australia Pty Ltd