Events

Safety Alert for IPLAN Planning Software and BRAINSCAN Software. Antivirus Registration No. 80042070008. Affected models: iPLAN RT Image (versions prior to Version 4.1.2), iPLAN RT and BrainSCAN (discontinued).

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
    1726
  • Date
    2015-11-13
  • 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
    Except for TC or standardized SUV (Standard Absorption Value) PET, Brainlab software only supports image sequences that contain a uniform calibration of pixel values ​​assigned by the image acquisition device (scanner) for all images, for all slices of the sequence. If such unsupported image sequence is used with Brainlab software, Brainlab software will apply the same pixel value calibration contained in the center image crop of the image sequence to all cuts. If multiple pixel value calibrations are contained in the other cuts of the unsupported sequence, those pixel values ​​will be configured with the same uniform calibration during loading: in a PET image sequence these uniformly calibrated pixels may have a different activity value, and will be displayed with different brightness and color compared to cropping images displayed by the scanner using varying calibrations. If it occurs during the use of an unsupported image sequence, this effect may be misleading to the customer during treatment planning, resulting, for example, in the incorrect definition of volumes of interest in the planning software. Objects created for these volumes of interest may differ in location or dimension relative to the actual and desired definition of the structure. If this is not detected by the user during treatment planning, target volumes may be erroneously defined for an irradiation schedule.
  • Reason
    Possible incorrect calibration of pixel for images (except for tomography and standardized pet for suv). as a result, objects created for volumes of interest may differ in location or dimension relative to the actual and desired definition of the structure. if this is not detected by the user during treatment planning, target volumes may be erroneously defined for an irradiation schedule.
  • Action
    The company will perform a product field correction (software update). Recommendations for Product Users: Except for CAT scans and PET images used with SUV, only use iPlan RT / iPlan RT Image to load and use image sequences that have the same pixel value calibration for all images in the sequence. Before using image sequences loaded in Brainlab's Irradiation Treatment Planning Software, always compare the images displayed in the Brainlab application with the images displayed by the imaging device (scanner), p. eg using a display medium other than Brainlab software, which is approved and available at the hospital. Please exclude and do not use image sequences in iPlan RT if any deviation is detected and contact Brainlab support. See additional information in the company's alert message, available at: http://portal.anvisa.gov.br/wps/wcm/connect/599e7d004a912b5e8eb8bf486c3ae08b/Assessment+of+Seguran+in+Camp+-+Notifica% C3% A7% C3% A3o + of + Product.pdf? MOD = AJPERES

Device

IPLAN Planning Software and BRAINSCAN Software. Antivirus Registration No. 80042070008. Affected ...

Manufacturer

BRAINLAB LTDA.; BRAINLAB AG
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    ANVSANVISA