Events

Retiro De Equipo (Recall) de Navigational System II - Cart(Surgical navigation system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-2015-RN-00619-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-14
  • 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-2015-RN-00619-1
  • 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
    Between may 2012 and july 2014, ondal medical systems gmbh received three complaints from customers where a broken joint of the articulated arm was reported. for two of the complaints the parts failed directly after installation of the device, for the other complaint, the part failed after six months. the load attached to the arm was in all three cases was approximately 18 kg.Additional inspection is required because there is a potential that the weld seam between the main stud and the two flaps on the articulated arm was not welded in the correct location, which may result in a potential failure of the arm joint.
  • Acción
    Stryker is requesting hospitals to check all stock areas and/or operating room storage and quarantine all affected equipment. A Stryker Representative will contact your facility to set up a time to perform the additional inspection of the weld seam on the Navigation System II-Cart, Articulated Arm Camera. This action has been closd-out on 15/08/2016.

Device

Navigational System II - Cart(Surgical navigation system)
  • Modelo / Serial
    Navigational System II - Cart(Surgical navigation system)Catalogue number: 7700-100-000Cart Serial Number: 100968, 100969Arm Serial Number: 11102258470, 11102258469ARTG Number: 127497
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA