Events

Safety Alert for Trade Name: ELEKTA PLANNING SYSTEM Technical Name: ANVISA Registration Number: 80569320003 Hazard Class: III Model Affected: Monaco Serial Numbers Affected: Monaco 5.10.2

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
    2179
  • Date
    2016-10-17
  • 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
    Prior to treatment, independent and secondary findings of dose calculation and UM should be performed. Both checks should be standard clinical radiotherapy practices and will detect the problem. 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. Clients should follow the directions in the Field Action release until corrections are implemented.
  • Reason
    Incorrect monitoring unit scale when creating 3d plans using um or dose-weighted modes, if the user changes the number of fractions and / or dose rx desired by the physician and then modifies the angle of the wedge, the value of the one will be scaled incorrectly. the um scale is directly proportional to the fractional change.
  • Action
    Field Action Code FCA-IMS-0017 triggered under the responsibility of Elekta Medical Systems Comércio e Serviços Radiotherapy Ltda. Company will make correction in the field.

Device

Trade Name: ELEKTA PLANNING SYSTEM Technical Name: ANVISA Registration Number: 80569320003 Hazard...

Manufacturer

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