Events

Safety Alert for Commercial Name: ELEKTA PLANNING SYSTEM Technical Name: ELEKTA PLANNING SYSTEM ANVISA Registration Number: 80569320003 Hazard Class: III Model Affected: Monaco Serial Numbers Affected: Monaco 5.00 and above

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
    2243
  • Date
    2017-03-13
  • 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 is detectable when following routine procedures to commission a beam model. A reminder can be used that when reinstalling a beam model, it is also necessary to repeat the quality control checks performed on the original model.
  • Reason
    Incorrect dynamic wedge (edw) or virtual wedge (vw) calculations the edw or vw wedge files can be loaded into the wrong energies using the drive unit storage. no notice or consistency check is performed on the edw or vw files when added to the database. the treatment unit storage should not allow or should display an error message if the user attempts to add an edw or vw file to a given power beam to a cone model file retracted at a different energy. currently the user is not warned if there is an incompatibility.
  • Action
    Field Action Code FCA-IMS-0021 triggered under the responsibility of Elekta Medical Systems Comércio e Serviços Radiotherapy Ltda. Company will make correction in the field.

Device

Commercial Name: ELEKTA PLANNING SYSTEM Technical Name: ELEKTA PLANNING SYSTEM ANVISA Registratio...

Manufacturer

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