Events

Alerta De Seguridad para EQUIPMENT FOR ANGIOGRAPHY ALLURA XPER, FD10 (ground); FD10 (ceiling); FD20 (ground); FD20 (ceiling); FD10OR Table; FD20 OTable; FD10 / 10; FD20 / 20 OR Table; FD20 / 10 OR Table; registry 10216710153 and 10216710206, hazard class III, series affected: 405/377.

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
    1715
  • Fecha
    2015-05-15
  • 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
    According to the record holder's information, intermittent failure of fluoroscopy may result in a temporary discontinuation of procedures and delay in treatment. #### UPDATED ON 7/18/2017, the company issued a completed field action report confirming the performance of correction, as provided.
  • Causa
    Software failure that can lead to intermittent and short-term unavailability of the fluoroscopy function.
  • Acción
    The company will update the software, installation of version R8.2.16.1, to correct the problem. The company clarifies that upon initiating fluoroscopy, the user may receive a "Fluoro failed, please retry" message and Fluoroscopy will be unavailable. Fluoroscopy repeat solves this situation in most cases. The user may need to repeat more than once in approx. 2% of events. The failure mode has no impact on the performance of active fluoroscopy. Once started, performing an active fluoroscopy continues until the pedal is released.

Device

EQUIPMENT FOR ANGIOGRAPHY ALLURA XPER, FD10 (ground); FD10 (ceiling); FD20 (ground); FD20 (ceilin...

Manufacturer

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