Events

Retiro De Equipo (Recall) de Radiolucent Spine Surgery Frame

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getinge 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-2018-RN-00024-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-12
  • 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-2018-RN-00024-1
  • 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
    Getinge has become aware of a potential risk, which could result in critical harm to the patient if the base of the product were to crack during use. since the introduction of this product in march 2017, one complaint with no allegation of injury has been reported where the base of the frame cracked as the patient was being prepared for surgery.
  • Acción
    Getinge Australia is advising customers to immediately remove the Spine Frame from use that are in the serial number range as identified. Getinge Australia representative will contact users to arrange the corrective repair.

Device

Radiolucent Spine Surgery Frame
  • Modelo / Serial
    Radiolucent Spine Surgery Frame Material Number: 100731AOModel Number: F-70801Multiple Affected Serial NumbersARTG 236335
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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