Events

Retiro De Equipo (Recall) de Device Recall Brainlab AG

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Brainlab AG.

¿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
    72804
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0647-2016
  • Fecha de inicio del evento
    2015-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142244
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System,planning,radiation therapy treatment - Product Code MUJ
  • Causa
    Large objects with fine resolution are potentially displayed cropped when imported into brainlab brain metastases 1.0.0.
  • Acción
    Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 5, 2015, to all direct accounts informing the of the recall and actions to be taken. User Corrective Action: Users of Brain Metastases Version 1.0.0 or Adaptive Hybrid Surgery Analysis 1.0.0 shall adhere to the following: After import always carefully review and verify all objects for correctness and validity. For reviewing an object, select the image set which was used to outline or to modify the objects in the Data menu. Also compare the contours of an object in Brain Metastases or Adaptive Hybrid Surgery Analysis software to the contours in SmartBrush. Please note that the error will not be visible in SmartBrush. Always verify the correct shape of the objects in Brain Metastases or Adaptive Hybrid Surgery Analysis software. If possible do not use image data sets with large slice distance and/or with a low amount of slices. To retrospectively identify if cropped objects have been used for treatment planning, the object contours of a specific treatment plan can be reviewed in Brainlab Dose Review, where the error will also be visible. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact affected customers tentatively starting February 2016 to schedule the update. The request that users advise the appropriate personnel working in their department of the content of the Notification letter. If the user facilities require further clarification, thay can contact their local Brainlab Customer Support Representative. Customer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers) E-mail: support@brainlab.com (for US customers: us.support@brainlab.com) Fax: Brainlab AG: + 49 89 99 15 68 33

Device

Device Recall Brainlab AG
  • Modelo / Serial
    Brain Metastases version 1.0.0  Model/catalogue number Description 21702-04 ELEMENTS AUT. BRAIN METASTASES PLAN INST 21703-01 ELEMENTS ADAPT HYB SURG ANALYSIS LICENSE 21703-02 ELEMENTS ADAPT HYB SURG ANALYSIS INST 21702 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-12 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-36 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-60 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21703 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-12 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-36 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-60 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21713 ELEMENTS ADAPTIVE HYBRID SURG. ANALYSIS 21722 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-12 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-36 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-60 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21723 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-12 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-36 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-60 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21732 ELEMENTS AUTOMATIC BRAIN METS PLAN. 12M
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.
  • Descripción del producto
    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Dirección del fabricante
    Brainlab AG, Kapellenstr. 12, Feldkirchen Germany
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    USFDA