Events

Alerte De Sécurité sur Trade name of the product: SYMBIA MARCA SIEMENS SPECT / CT EQUIPMENT (registration number: 10345161973); SPECT SYSTEM (registration number: 10345161991), E.CAM SIGNATURE SERIES MARK SIEMENS (registration number: 10234230040) /// affected lots: see file "Product description MI002 / 16 / S.pdf" / / Product risk class : II and III.

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; 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
    1879
  • Date
    2016-04-21
  • 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
  • Cause
    The company "has determined that e.Cam or symbia systems with predictive detectors performing dynamic or gateway acquisitions may lose detector date / time information." research shows that "the resulting risk is that the image data frame and the ejection fraction value calculated are smaller. although erroneous diagnoses are a possibility, if ejection fraction values ​​are used as the sole source of diagnosis, we were not informed of such events. ".
  • Action
    Field classification: letter to client /// Field action code: MI002 / 16 / S /// Recommendations to users and patients: one can continue to use the system; make sure that this warning is included in the instructions for use of the system. We also ask that customers await the release of the update that aims to correct the error mentioned in this field action. To reduce the chances of occurrence, follow the Shutdown and Startup instructions as described in the User's Guide.

Device

Trade name of the product: SYMBIA MARCA SIEMENS SPECT / CT EQUIPMENT (registration number: 103451...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Medical Solutions USA, Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA