Events

Alerte De Sécurité sur ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000, Registration 10234230166 - Serial Numbers: 400723; 400758; 401532.

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
    1679
  • Date
    2015-08-26
  • 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
    Siemens Ltda reports the potential risk is that the Echocardiogram under Effort study must be performed again. It further informs that the problem will be solved by launching new software for customers who have not yet received the original software update.
  • Cause
    Siemens healthcare has identified that when conducting a 2d stress echocardiography study, there is a possibility of data loss in the acuson sc2000 system, in which selected videos can not be saved as part of the study.
  • Action
    The company advises that, in order to avoid possible risk, the following steps should be followed: - Select "Stress echocardiography"; - If applicable, reclassify videos from all stages and views; - Do not return to "Stress Echo Screening" to select reclassified additional videos. In addition, after inserting the stress echocardiography review, the selection of stress echocardiography should not be reinserted and additional images or videos should be selected. For more information, see Appendix Letter to the customer and through the company service center.

Device

ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000, Registration 10234230166 - Serial Numbers: 400723; 40...

Manufacturer

Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA