Events

Alerte De Sécurité sur LINEAR DIGITAL ARTISTE CELERATOR - 10234230172 - Risk class III. Serial Numbers: 10514 (Artiste syngo RT Therapist model) and 10321 (Artiste syngo RT Oncologist model).

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1773
  • Date
    2015-12-18
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA