Events

Safety Alert for Trade name: ELEKTA PLANNING SYSTEM; ANVISA registration number: 80569320003; Risk class: III; Affected model (s): Monaco version 5.10; lot / series (local distribution district / UF): 5.10.02 (4 in São Paulo-SP, 1 in Belo Horizonte-MG, 1 in Santa Maria-RS); 5.10.00 (1 in Rio de Janeiro-RJ); 5.10.02 (1 in Pouso Alegre-MG)

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; 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
    1906
  • Date
    2016-06-07
  • 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
    Case of doubts about this action phone call: 8008784267
  • Reason
    Incorrect field size when dicom exporting monaco plan with composite field sequencing will fit in the port format when they remain where they are set. this runs when the shape of the door used to define or edit the mlc positions extend beyond or within the current grip positions. the defect was triggered when using an outdated workflow for the imrt planning for the future imrt which requires the creation of multiple beams for the same gantry angle with a single mlc format defined for each beam. these beams are then exported using cfs. there may be a possibility of a change in treatment planning, which could change the dose site and the amount received.
  • Action
    Action code FCA-IMS-0013. Software update /// Letter to customers elaborated on 06/03/2016.

Device

Trade name: ELEKTA PLANNING SYSTEM; ANVISA registration number: 80569320003; Risk class: III; Aff...

Manufacturer

Elekta Medical Systems Comércio e Serviços Radioterapia Ltda; IMPAC Medical Systems, Inc.
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    ANVSANVISA