Events

Safety Alert for EXACTRAC LOCATION SYSTEM. ANVISA registration no. 80042070004.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BRAINLAB 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
    1246
  • Date
    2013-04-18
  • 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 anomaly was detected in EXACTRAC 5.x when it is used with a Treatment Planning System (TPS) not produced by BRAINLAB. The anomaly may mislead the user when he selects a treatment plan / isocenter (radiation treatment target) in EXACTRAC for patient positioning on the linear accelerator (linac). The following versions of EXACTRAC are potentially affected: 5.0 (5.0, 5.0.1, 5.0.2) and 5.5 (5.5, 5.5.1, 5.5.2). See the Field Security Notice issued by the company for additional information. #### UPDATE (06/14/2013): The field action was terminated by the company on 05/08/2013.
  • Reason
    Possibility of unintentional mixing of two planes, initially separated, from the same patient.
  • Action
    The company will initiate a software update to fix the problem. Until the problem is corrected users should follow the recommendations contained in the USER'S CORRECTIVE ACTION section of the Field Safety Notice issued by the company to mitigate the risks related to this problem. the Notice of Field Security is available at: http://portal.anvisa.gov.br/wps/wcm/connect/77dad1804f4f50a78b86dbd785749fbd/Aviso_de_Seguranca.pdf?MOD=AJPERES

Device

EXACTRAC LOCATION SYSTEM. ANVISA registration no. 80042070004.

Manufacturer

BRAINLAB LTDA.
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    ANVSANVISA