Events

Alerta De Seguridad para Trade Name: FLUOROSCOPIC SYSTEM OF X-RAYS AXIOM Luminos dRF - 10345161987 - Class of risk III. Serial Numbers: 3141; 3142; 3144; 3174.

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 AG; Siemens Healthcare GmbH.

¿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
    1946
  • Fecha
    2016-06-16
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    Recommendations to Users and Patients: Users and patients may continue to use the system normally until the software update is performed by one of Siemens' technicians. And if there is any deviation in the operation of the equipment, it must be reported immediately to Siemens.
  • Causa
    Siemens healthcare sa informs that outdated software points to two problems: sporadic dosing failure and brake failure in the overload tube. there may be an out-of-specification dose during a test and the overload tube may swing down in the event that the equipment's current software does not activate the brakes. both problems will be fixed with the new software version.
  • Acción
    Action code XP056 / 14 / S: Recommendations to users and patients ///// Software Update.

Device

Trade Name: FLUOROSCOPIC SYSTEM OF X-RAYS AXIOM Luminos dRF - 10345161987 - Class of risk III. Se...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Healthcare GmbH
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA