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 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
    2180
  • 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
    Recommended user action: The problem can be avoided if the user performs the following actions: - Following the edits of the contour, perform an "Unload All" and reload the plan before performing the dose calculation.
  • Reason
    Contours are not handled correctly if the tc data set contains cuts with coordinates dicom z d xx.X50mm. if ct data has cuts occurring in the xx.X50mm position, there may be portions of the volume where there is an incompatibility between the contour graphics displayed on the screen and the contour data used during dose optimization and calculation. unloading and reloading patient data solves the problem.
  • Action
    Field Action Code FCA-IMS-0019 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