Events

Safety Alert for Trade name: ELEKTA PLANNING SYSTEM Technical name: ELEKTA PLANNING SYSTEM ANVISA registration number: 80569320003 Hazard class: III Model affected: Monaco Serial numbers affected: Monaco 5.11 and 5.20

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by 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
    2065
  • Date
    2016-12-05
  • 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
    The problem can be avoided by forcing a new calculation on Monaco® (change the spacing of the dose calculation grid and return again) when any change in wedge angle is made. Prior to treatment, independent verifications of the dose calculation and the secondary UMs should be performed. Both checks should be standard clinical radiotherapy practices and will detect the problem.
  • Reason
    The dose can be incorrectly calculated by using the reset function on monaco®. when creating 3d plans using the dose weighing mode, if you reset the plane, select "reset" and then change the angle of the wedge, the plane dose and the monitor units (um) must be returned to their original values ​​before the reset is performed. however, the system correctly restores the edited wedge fields, but incorrectly applies the readjusted values ​​to all other beams in the plane.
  • Action
    Field Action Code FCA-IMS-0018 triggered under the responsibility of Elekta Medical. Company will make correction in the field.

Device

Trade name: ELEKTA PLANNING SYSTEM Technical name: ELEKTA PLANNING SYSTEM ANVISA registration num...

Manufacturer

IMPAC Medical Systems, Inc.
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    ANVSANVISA