Events

Safety Alert for Digital Linear Accelerator ARTISTE, Registration 10234230172 - Serial Numbers: 5746; 5828; 5867.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc. Oncology.

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
    1495
  • Date
    2015-01-19
  • 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 registry holder informs that if there is plaque overheating, there is potential for a fire or even smoke emission from the system to be inhaled and consequently medical treatment may be required, depending on the patient's distance and the amount of smoke emitted.
  • Reason
    Siemens has identified a possible occurrence of sporadic failure of overheating signals on the g41 motherboard, located within the gantry of the linear accelerator. one of the components belonging to the printed circuit board (pcb of the head driver) was determined as the root cause.
  • Action
    Siemens has redesigned the Hard Driver PCB card to further mitigate the risk of local superheat of the G41 motherboard and is guiding customers to wait for the patch to be replaced in the field to replace the card for which it has been redesigned, to file the letter to the client, and follow the guidelines contained in the letter.

Device

Digital Linear Accelerator ARTISTE, Registration 10234230172 - Serial Numbers: 5746; 5828; 5867.

Manufacturer

Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc. Oncology
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA