Events

Safety Alert for MOSAIQ Oncology Information System. Anvisa Registry n ° 80569320004.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by IMPAC Medical Systems Inc; Elekta Medical Systems Ltda..

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
    1629
  • Date
    2015-07-10
  • 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
    A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic planes using cones. Affected sites will be those satisfying ALL of the three criteria below: 1. Running MOSAIQ Version 2.41 and higher; 2. With at least one linac equipped with an Agility 160 MLC head (Versa HD, Infinity, Axesse (EOS) or Synergy); and 3. Who is dealing with Stereotactic Cones. The problem can be avoided by clicking Cancel in the Create MLC Simple Window window by editing the field dimension in the Create MLC Simple window to return to the correct MLC format for the planned cone before saving or not using the Simple MLC view. Additional information at http://portal.anvisa.gov.br/wps/wcm/connect/b84a4980490e7d57a854b905df47c43c/Aviso+de+Seguran%C3%A7a.pdf?MOD=AJPERES
  • Reason
    Incorrect field size for stereotactic cones, which may result in radiation overdose in the patient.
  • Action
    Software correction.

Device

MOSAIQ Oncology Information System. Anvisa Registry n ° 80569320004.

Manufacturer

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