Events

Safety Alert for Model affected: Monaco Serial numbers affected: Monaco 5.10.2, 5.11.0, 5.11,1

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
    2275
  • Date
    2017-01-31
  • 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
    If a new calculation is made after the numbering of the beams is edited and the angle of the wedge is modified, the problem solves itself.
  • Reason
    Incorrect dose after editing beam numbering and wedge angle the dose calculated from the wedge beams can be assigned to the wrong beam. this can occur in a plane with at least two beams using the elekta motorized wedge. when the user changes the numbering (beam index) relative to the two wedge beams that are left with the beams exchanged, and then edit the wedge angle of one of the beams. the numbering of the beams is in the first column of the beams spreadsheet.
  • Action
    Field Action Code FCAIMS0022 triggered under the responsibility of Elekta Medical Systems Comércio e Serviços Radiotherapy Ltda. Company will make correction in the field.

Device

Model affected: Monaco Serial numbers affected: Monaco 5.10.2, 5.11.0, 5.11,1

Manufacturer

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