Events

Safety Alert for Product: RT Elements. Models: Brain Metastases Elements and Adaptive Hybrid Surgery Analysis Elements. Anvisa Registration n ° 80042070036.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Brainlab Ltda; Brainlab AG.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1792
  • Date
    2016-01-14
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    The manufacturer assessed the situation and concluded that: In the case of Brain Metastases, if the trimmed object is not recognized by the user before the plan is used for treatment and the deviation exceeds the clinically acceptable limits, this may result in ineffective radiation treatment and the patient's health risk can not be excluded. In the case of the Adaptive Hybrid Surgery Analysis Elements, when evaluating a possible radiotherapeutic treatment the incorrect information displayed may have an effect on clinical decisions. If the evaluation of different treatment options is performed during surgery, this may even, in a worst-case scenario, confuse the patient in relation to the evaluation of the extent of resection during this surgery.
  • Reason
    Large objects with high resolution are potentially displayed with cutouts when imported into brain metastases elements and adaptive hybrid surgery analysis elements.
  • Action
    This is a software update initiated by the company. Users of Brain Metastases Version 1.0.0 or Adaptive Hybrid Surgery Analysis 1.0.0 should note the following instructions: After importing, always review and carefully check for the correctness and validity of all objects. To review an object, select the sequence of images that was used to bypass or modify the objects in the Data menu. Also compare the contours of an object in the Brain Metastases or Adaptive Hybrid Surgery Analysis software with the contours in the SmartBrush. Note that the error will not be visible in SmartBrush. Always verify that the shape of the objects is correct in Brain Metastases or Adaptive Hybrid Surgery Analysis software. If possible, do not use series of image data with long cut distance and / or a small number of cuts. To check retroactively whether scrap objects were used for treatment planning, the contours of the objects in a specific treatment plan can be reviewed in the Brainlab Dose Review software, where the error will also be visible. Company code for the field action: CAPA-20151029-001528.

Device

Product: RT Elements. Models: Brain Metastases Elements and Adaptive Hybrid Surgery Analysis Elem...

Manufacturer

Brainlab Ltda; Brainlab AG
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    ANVSANVISA