Events

Safety Alert for Trade name: Linear Accelerator Elekta. Technical Name: Linear Accelerator. ANVISA registration number: 80569320007. Risk class: III. Affected model: Integrity R1.2 .. Affected serial numbers: See list of affected lots attached in Anvisa portal - link: http://portal.anvisa.gov.br/informacoes-tecnicas13/-/asset_publisher/WvKKx2fhdjM2/content /home % 3DF% 3Dview% 3Dp% 3Dview% 26p_p_col_id% 3Dcolumn% 3pp% 3D2% 26p_p_col_count% 3D5% 26p_p_col_count% 3D5% 26p_p_col_count% 3D5%

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Elekta Medical Systems Comércio e Serviços Radioterapia Ltda; Elekta Ltd.

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
    2472
  • Date
    2018-01-18
  • 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
    Read and follow the 200-01-502-053 Field Action Safety Notice and send the signed acknowledgment of receipt of the document to your Elekta representative as soon as possible. Please allow Elekta Service representatives to access the Unit to install the patch modification when it is launched. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Adverse Event (AE) and Technical Complaints (QT) for products subject to Sanitary Surveillance should be done through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    Potential for positional errors after automatic table movement (atm) elekta has identified that it is possible to obtain a positional error with the precise treatment table ™ after automatic table movement. this may occur if there is an undetected failure of the position sensors. this problem was previously reported through 200-01-204-011 notification. the precise treatment table is equipped with sensors that achieve a high degree of reliability when reading the table position. if there is an undetected fault on one of these sensors, a positional error can be obtained with the precise treatment table ™ after automatic table movement when using the xvi and mosaiq ™. the system has a software check to detect large positional errors resulting from sensor malfunction. in these cases, it is possible to position the treatment table with errors greater than 5 mm without any inhibitions. this may occur if automatic table movement is used. if automatic table movement is performed by iguide, positional error is detected.
  • Action
    Field Action Code FCA-EL-0004 triggered under the responsibility of Elekta Medical Systems Comércio e Serviços Radiotherapy Ltda. Will make field correction

Device

Trade name: Linear Accelerator Elekta. Technical Name: Linear Accelerator. ANVISA registration nu...

Manufacturer

Elekta Medical Systems Comércio e Serviços Radioterapia Ltda; Elekta Ltd
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    ANVSANVISA