Events

Retiro De Equipo (Recall) de Oncentra Brachy using versions 4.5, 4.5.1 and 4.5.2

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Nucletron Pty Limited.

¿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-2017-RN-01069-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-16
  • 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-2017-RN-01069-1
  • 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
    Elekta has identified an issue with oncentra brachy with the default step size set in rdstore.The measured source paths for a ring-type applicator have a source step size of 2.5mm for the microselectron afterloader. when creating a plan for a ring applicator with a measured source path, the step size will be used for the entire plan. if such an applicator model is used while the default step size of the afterloader is 5.0, the step size in the ring or lunar-shaped ovoids will be incorrect. they will be shown as 2.5mm, while the afterloader will deliver at 5.0mm if the error is not detected during plan approval.If this plan is exported to the microselectron treatment control system (tcs) and delivered, the treated dwell positions in the ring will be incorrect. when loading the plan in tcs only the dwell position numbers and source step size are taken over from the oncentra brachy plan. this leads to a shift of the treated dwell positions in the ring due to the incorrect step size.
  • Acción
    Until an upgraded version of Oncentra Brachy is available, users are strongly recommended to use a default source step size of 2.5mm for microSelectron afterloaders in RDStore. If a larger default source step size is required in RDStore, a workaround is to reselect the same after loader in the Prescription dialog in the Oncentra Brachy planning module. The source step size is then forced to the correct value of 2.5mm. Users are advised to perform proper Quality Assurance for all treatment plans before delivery of the first fraction to the patient. The issue will be solved in the next version of Oncentra Brachy.

Device

Oncentra Brachy using versions 4.5, 4.5.1 and 4.5.2
  • Modelo / Serial
    Oncentra Brachy using versions 4.5, 4.5.1 and 4.5.2Reference Number: FCA-NU-0004ARTG Number: 142110
  • Manufacturer
    Nucletron Pty Limited

Manufacturer

Nucletron Pty Limited