Events

Safety Alert for LINEAR DIGITAL ARTISTE CELERATOR - 10234230172 - Risk class III. Serial Numbers: 10514 (Artiste syngo RT Therapist model) and 10321 (Artiste syngo RT Oncologist model).

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
    1773
  • Date
    2015-12-18
  • 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 company Siemens informs that it is working to find a software solution to properly solve the problem described in the TH011 / 15 / S field action. Once the solution is available, the systems identified will be updated as soon as possible.
  • Reason
    The company reports a possible patient-related safety issue when using the adaptive targeting option in the syngo rt therapist and the syngo rt oncologist (versions 4.3.138, 4.3.Sp1, 4.3.1_ar1 or 4.3.1_mr2 ) in combination with multiple isocenters based on a planning ct. the described problem occurs if one or more treatment plans with at least 2 isocenters based on a planning ct are used and when a conical beam ct was acquired for each isocenter. the system supports the workflow correctly until the user makes a manual change to another isocenter. at this time, the overlapping images in adaptive targeting may be incorrect.
  • Action
    The company recommends users and patients: Always use automatic registration after a manual change to another isocenter before using manual registration. Therefore, for all security measures, all affected customers should implement this recommendation and immediately inform all persons who may be involved in such a question. (Field Action Code TH011 / 15 / S)

Device

LINEAR DIGITAL ARTISTE CELERATOR - 10234230172 - Risk class III. Serial Numbers: 10514 (Artiste s...

Manufacturer

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