Events

Safety Alert for Radiation Treatment Planning System / FOCAL Model. Anvisa Registration No. 80569320008. Version 4.80.00 of the FOCAL model.

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 PARA RADIOTERAPIA LTDA.; IMPAC Medical Systems, Inc.

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
    1489
  • Date
    2015-01-12
  • 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
    When a CT phantom is scanned and the images are transferred to the Focal, you can sample the densities using the Image Statistics tool in Focal. In the case where the thickness of the CT slice is not equal to the spacing of the CT slice, the Image Statistics tool will report an incorrect HU. If you base your CT-to-ED file on this incorrect density information, this will result in errors in the calculation of the dose. The magnitude of the error in the dose calculation will depend on the magnitude of the HU error. The problem occurs when the CT Slice Spacing is not equal to the CT Slice Thickness, and the Image Statistics tool information is used to populate the CT-to-ED file. According to the company's risk assessment, Focal will assign an incorrect density that will lead to errors in the dose, which can result in adverse consequences without serious health. Check information in the Important Notice to the User, available at http://portal.anvisa.gov.br/wps/connect/57699e8046ec7179a7c6b741cdd33a01/Amanda+Importante+to+Usu%C3%A3rio+-+FOCAL+7.pdf?MOD = AJPERES.
  • Reason
    Possibility of error in the calculation of the therapeutic dose of radiation, under specific conditions of use of the product.
  • Action
    Equipment operators must read, complete and send the Important User Notice form to Elekta as soon as possible (30-day deadline). The solution (software update) should be implemented by Elekta technical assistance as soon as possible. The Important User Notice form is available at http://portal.anvisa.gov.br/wps/wcm/connect/57699e8046ec7179a7c6b741cdd33a01/Amanda+Importante+to+Usu%C3%A3rio++++++++++++++++++.pdf?MOD = AJPERES.

Device

Radiation Treatment Planning System / FOCAL Model. Anvisa Registration No. 80569320008. Version 4...

Manufacturer

ELEKTA MEDICAL SYSTEMS COMÉRCIO E SERVIÇOS PARA RADIOTERAPIA LTDA.; IMPAC Medical Systems, Inc
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    ANVSANVISA