Events

Safety Alert for Trade Name: DIGITAL ARTISTE LINEAR ACCELERATOR. ANVISA registration No. 10234230172. Risk class III. List of lots / series: 10587; 10852.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A Endereço; 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
    1888
  • Date
    2016-04-20
  • 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
    Recommendation to users and patients: Add a manual pause between the treatment fields if you want the system to stop / pause the treatment to move the table and the gantry manually.
  • Reason
    Siemens healthcare diagnostics sa has identified a problem due to the change of syngo rt therapist software in combination with the isocentric table rotations. there are two situations where the problem may occur: situation 1: when the "automatic movement" is configured a certain message will not be displayed, no pause will be added resulting in the automatic movement of all the programmed positions. situation 2: when "manual movement" is configured, the pause will not be added automatically and in this case the gantry can move before the table movement is performed.
  • Action
    The Siemens-initiated field action code TH001 / 16 / S deals with a Risk Letter III Customer Submission (situation in which there is a low probability that the use or exposure to a health product may have adverse health consequences ). Recommendation to users and patients: Add a manual pause between the treatment fields if you want the system to stop / pause the treatment to move the table and the gantry manually.

Device

Trade Name: DIGITAL ARTISTE LINEAR ACCELERATOR. ANVISA registration No. 10234230172. Risk class I...

Manufacturer

Siemens Healthcare Diagnósticos S.A Endereço; Siemens Medical Solutions USA Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA