Events

Alerte De Sécurité sur Equipment for angiography Artis. Model: Artis Zeego. Anvisa Registry n ° 10234230158.

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 Ltda..

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
    1452
  • Date
    2014-10-24
  • 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 overseas manufacturer performed the problem analysis, evaluating all the inherent risks, which generated corrective action in the field. Based on the investigation and mitigation of the risk conducted, this action was classified as a medium risk to health, its severity being critical and its probability of occurrence extremely unlikely. According to the company, this is a possible hardware failure that has no influence on the treatment of patients. The customer will be advised to wait for the Service Team to schedule field corrections and to file the letter with the Operator's Manual. In addition, Siemens advises to inform all personnel of the organization who need to be aware of this problem and act accordingly. According to the company the field action was finalized
  • Cause
    A cable inside the c-arm of affected systems may have been improperly positioned. without an additional measure, there is the possibility of a cable inside the c-arm. the problem will not occur systematically but sporadically over the lifetime of the system.
  • Action
    Correction in the field / Correction of parts or parts.

Device

Equipment for angiography Artis. Model: Artis Zeego. Anvisa Registry n ° 10234230158.

Manufacturer

Siemens Healthcare Diagnósticos Ltda.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA