Events

Safety Alert for EXACT TARGETING MESA, component of the following products: ACUITY RADIAC THERAPY SIMULATOR (Anvisa 10405410008), LINEAR ACCELERATOR CLINAC IX AND ACCESSORIES (Anvisa Reg 10405410012), VARIAN RADIOTHERAPY SYSTEM (10405410011), CLINAC RADIOTHERAPY LINEAR ACCELERATORS (10405410001) and LINEAR HIGH-ENERGY RADIOTHERAPY ACCELERATOR CLINAC (10405410010).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Varian Medical Systems Brasil Ltda.; Varian 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
    1037
  • Date
    2010-12-15
  • 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 EXaCT Targeting table is a complex mechanical device that can trap and injure the extremities of the human body, especially the fingers. Documentation already provided by Varian for this table includes warnings about these risks and instructions for safe use of the table. According to Varian, in the past mitigation measures have been taken.
  • Reason
    Grooves on the tables can hold and injure parts of the operator's or patient's extremities, such as the fingers and toes.
  • Action
    Users of Exact Targeting should pay attention to the following instructions: Read and follow the recommendations and safety instructions in the user manual that came with the product, especially the chapter "Hazard and Safety Precautions" ). Maximum caution is advised when two people handle the table simultaneously. Patients should be advised to hold only the appropriate handles and guides on the table to avoid inserting their fingers into risky places. For detailed safety instructions, please read the Urgent Safety Notice posted by the manufacturer of the product at: http://portal.anvisa.gov.br/wps/wcm/connect/313eef8045112cd3ac7daeb34d2284eb/VarianSecurity Notice. pdf? MOD = AJPERES.

Device

EXACT TARGETING MESA, component of the following products: ACUITY RADIAC THERAPY SIMULATOR (Anvis...

Manufacturer

Varian Medical Systems Brasil Ltda.; Varian Inc.