Alerta De Seguridad para 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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A; Siemens Medical Solutions USA, Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1849
  • Fecha
    2016-03-30
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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. "
  • Causa
    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.
  • Acción
    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.

Manufacturer