Events

Retiro De Equipo (Recall) de iPlan RT Dose / iPlan RT Versions 4.5.3 and 4.5.4, when used in combination with the optional function Dose Planning for Agility Multileaf-Collimator (MLC)

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-2016-RN-01317-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-10-07
  • 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-2016-RN-01317-1
  • 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
    The agility mlc controller automatically adds a physical gap of 1mm (about 3mm projected to the isocenter) between opposing closed leaf pairs. therefore, leakage radiation through this gap must be correctly considered during treatment planning and dose calculation. due to a software inconsistency, the brainlab pencil beam dose calculation algorithm does not correctly regard and represent this gap if all of the following conditions are met:1. iplan rt dose v. 4.5.3 or 4.5.4 is used.2. the planning option for agility mlc is used for a treatment plan.3. the machine profile (dose profile entered in the brainlab treatment planning software) for the used agility mlc and linear accelerator combination contains a leaf shift static value different than 0mm.If the above described conditions are met, only specific plans irradiating multiple separate target volumes simultaneously with a single isocenter are affected.
  • Acción
    Users are advised to immediately check the Leaf Shift Static value in all the machine profiles in iPlan RT Dose for an Agility MLC: Ensure that this value is set to “0 mm”. If another value is found, please change this specific value to 0 in order to permanently resolve the described potential issue. The users are also reminded of the following information which is in the current IFU: - For any new or changed machine profiles, it is highly recommended to perform a dose verification (using a phantom) before clinical use, to ensure adequate implementation and accuracy of dose calculation. - Patient-specific Quality Assurance of a treatment plan and verifying the dose distribution (in a suitable phantom) is highly recommended before irradiating the patient. Brainlab will be offering a software solution and will contact affected customers starting November 2017 to implement the update free of charge.

Device

iPlan RT Dose / iPlan RT Versions 4.5.3 and 4.5.4, when used in combination with the optional fun...
  • Modelo / Serial
    iPlan RT Dose / iPlan RT Versions 4.5.3 and 4.5.4, when used in combination with the optional function Dose Planning for Agility Multileaf-Collimator (MLC)ARTG Number: 121114
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd