Events

Alerta De Seguridad para ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000. ANVISA registration no. 10345161999. Risk class II. Serial numbers: 401704 and 401809

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
    1846
  • Fecha
    2016-04-01
  • 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
    In case the reported problem occurs when the wheels are in the "unlocked" position and the user attempts to move the system, he may lose his balance. If the wheels are in the "locked" position and the user attempts to move the system, he may suffer damage or injury to the soft tissue.
  • Causa
    Siemens healthcare diagnósticos sa informs that the metal component used to engage the wheel lock can disconnect, preventing the user from locking and unlocking or steering the wheels.
  • Acción
    The field action code US035 / 15 / S initiated by Siemens deals with a field correction, parts and parts correction, with risk classification III (situation in which there is a low probability that the use or exposure to a health adverse health consequences). Recommendation to users and patients: Until the necessary repairs have been completed on your system, share this information with all employees in your health care facility who need to be aware of this problem.

Device

ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000. ANVISA registration no. 10345161999. Risk class II. S...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Medical Solutions USA, Inc
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA