Events

Retiro De Equipo (Recall) de Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient positioning during stereotactic radiosurgery or radiotherapy procedures using a linear accelerator)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Brainlab 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-2013-RN-00716-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-07-17
  • 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-2013-RN-00716-1
  • 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
    It has been detected that the pointer cap with the engraved cross hairs may become loose even when only a moderate force is applied to the pointer cap. due to the manufacturing tolerances specified the force to loosen the pointer cap may vary, depending on the individual pointer cap and aluminium pointer rod assembly. if this occurs, most likely the pointer cap will detach completely, rendering the target pointer no longer usable. in a scenario that the pointer cap would loosen but not detach completely, a shift of the pointer cap of up to 2mm might remain unnoticed. since the device is used for calibration and quality assurance of patient positioning technologies for radiation therapy treatments at a linear accelerator, this scenario might degrade the accuracy of the positioning solution used.
  • Acción
    Brainlab is requesting users to inspect stock and quarantine affected devices. Replacement stock will be provided to affected customers.

Device

Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient posit...
  • Modelo / Serial
    Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient positioning during stereotactic radiosurgery or radiotherapy procedures using a linear accelerator)Product Number: 43410Serial Number: 1223012002, 1223012007, 1223012008ARTG Number: 121226
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd