Events

Alerta De Seguridad para Allura CV20 X-ray system, risk class III, registry: 10216710186, batches affected: 87/154.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V..

¿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
    1621
  • Fecha
    2015-07-02
  • 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
    The audible fluoroscopy signal is a tool available to avoid unnecessary radiation to the patient. The non-ringing of the bell occurs very often. #### UPDATED ON 7/18/2017, the company submitted completion report of the field action proving the accomplishment of correction, as planned.
  • Causa
    The record holder has an intermittent electronic defect in the product. a software error may lead to non-activation of the fluoroscopy five-minute bell as required in 21cfr1020.32 (h) (2) (ii) and iec 60601-2-54, clause 203.6.2.1.C.
  • Acción
    The record holder's recommendations are that the user should always observe the real-time dose information and the cumulative fluoro time provided by the system. The company will update the software to correct the problem.

Device

Allura CV20 X-ray system, risk class III, registry: 10216710186, batches affected: 87/154.

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA