Events

Alerte De Sécurité sur Trade Name: DIGITAL ARTISTE LINEAR ACCELERATOR. ANVISA registration No. 10234230172. Risk class III. List of lots / series: 10587; 10852.

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 Healthcare Diagnósticos S.A Endereço; 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
    1888
  • Date
    2016-04-20
  • 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
    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.
  • Cause
    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.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA