Events

Alerte De Sécurité sur E.CAM SIGNATURE SERIES MARK SIEMENS - Camera Camcorder - Model E.CAM Signature Series, brand SIEMENS - Registration 10234230040 ### SPECT SYSTEM (Nuclear Image Formation System) - Symbia Model E; Symbia S - Record 10345161991 - VIEW PRODUCT DESCRIPTION

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
    1849
  • Date
    2016-03-30
  • 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
    According to the company: "Recommendation to users and patients: We recommend the users of the target devices of this field action to inform all responsible staff about these reinforcements of instructions that were made in the user manual. Continued use of the system is not impaired, meaning users can continue to use the systems. Also, we ask that users make sure that this safety information has been attached to the instructions for using the system. Finally, we always warn that all information regarding the use of systems should be available to all operators of the equipment. "
  • Cause
    Siemens healthcare informs that it has received complaints regarding incidents, which during the exchange of collimator activities have resulted in injury to the operator. it has been determined that while the existing user's manual is correct, additional add-ins with visual aids may promote clarity and appropriately emphasize the collimator process exchange.
  • Action
    The action of field code MI005 / 16 / S initiated by Siemens deals with a Letter to the Client, SEE LETTER TO CUSTOMERS AND DISTRIBUTION MAP.

Device

E.CAM SIGNATURE SERIES MARK SIEMENS - Camera Camcorder - Model E.CAM Signature Series, brand SIEM...

Manufacturer

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