Events

Safety Alert for LINEAR DIGITAL ARTISTE ACCELERATOR, Registration 10234230172 - Serial Numbers: 10233; 10321.

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..

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
    1678
  • Date
    2015-08-26
  • 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
    Siemens Ltda informs that the application of an incorrect deviation to the patient's position may result in undue treatment in terms of dose administration at the wrong location.
  • Reason
    Siemens has identified that by using the adaptive targeting option in the syngo rt therapist 4.3.Sp1 in combination with images acquired with ctvision, an incorrect deviation calculation may occur. applying an incorrect deviation to the patient's position may result in undue treatment of the patient in terms of dose administration at the wrong site.
  • Action
    The company performed the software update (new software syngo RT OncologistTM). It also states that the software update corrects this behavior and recommends attaching the security note to the User's Guide, chapter "Security Information Cards". For more information, see Appendix Letter to the customer and through the company service center.

Device

LINEAR DIGITAL ARTISTE ACCELERATOR, Registration 10234230172 - Serial Numbers: 10233; 10321.

Manufacturer

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