Events

Retiro De Equipo (Recall) de Leksell Gamma Knife Perfexion (teletherapy device indicated for stereotactic irradiation of head structures)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Elekta 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-2014-RN-01107-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-10-14
  • 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-2014-RN-01107-1
  • 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
    In leksell gamma knife perfexion, the coordinate frame is fixed to the patient positioning system before treatment using a frame adapter. the coordinate frame is locked to the frame adapter via latches. the latches shall be turned ninety degrees and then locked. the manufacturer has got a report that the latches may be locked before they have been fully turned resulting in a poorly locked frame. investigations show that it may be possible to have a situation where the adapter latches can get stuck just above the coordinate frame surface and as a result the coordinate frame will not be fixed properly. if the coordinate frame is not correctly locked to the frame adapter a play may occur and possibly move the target from planned position by up to 0.5 mm. there is a potential of mistreatment due to the patient being incorrectly positioned.
  • Acción
    Elekta has initiated more stringent measurements in manufacturing and will check/replace affected frame adapters in the field. Meanwhile, the users are advised the following: - Always assure that the plastic lever is only operated when at a right angle with the frame adapter. - Do not force the plastic lever in place if it meets significant resistance when turned. - Ensure that the plastic lever is completely flush with the frame adapter and that no angulations are present. This action has been closed-out on 06/09/2016.

Device

Leksell Gamma Knife Perfexion (teletherapy device indicated for stereotactic irradiation of head ...
  • Modelo / Serial
    Leksell Gamma Knife Perfexion (teletherapy device indicated for stereotactic irradiation of head structures)Frame Adapter Serial Numbers: FV001 to FV376ARTG Number: 182102 & 182943
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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