Alerta De Seguridad para Equipment for Angiography INTEGRIS ALLURA with VELARA GENERATOR, registered in Anvisa under the number 10216710154 - Lot / Serial No. - according to the attached distribution list.

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.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    Since this is an intermittent fault, no solution is available and no action can be taken by the user to prevent the fault from occurring. If the problem occurs, the System should be rebooted either hot or cold. (see instructions for use) If this does not work, Local Assistance should be contacted. If you need additional information or support regarding this issue, please contact our Solution Center at 0800-701-7789. Call Monday to Friday and Saturdays from 7:00 a.m. to 7:00 p.m. Anvisa is following this action.
  • Causa
    Due to intermittent shortcuts within the velara generator, a system lock may occur and can be resolved only by a warm or cold restart of the system. in exceptional cases, the generator is corrupted and the system can not be reinitialized. when a system is locked during a critical intervention case, this can result in serious injury to patients. a warm restart requires approximately 90 seconds, while a cold restart requires about 4 minutes. during reboot, the system can not be used.
  • Acción
    ACTIONS PLANNED BY PHILIPS: A mandatory FCO will be issued to resolve this problem. Depending on the type of the System, the FCO numbers will be: 72200167 Allura Integris and Xper Monoplane systems with the Velara Generator; 72200168 Allura Integris and Xper Biplane systems with the Velara Generator; The FCO will contain the Software and Hardware modifications. The expected date of issue for these FCOs will be April 2010. You will be contacted by Philips for the implementation of the corrective action.


  • Empresa matriz del fabricante (2017)
  • Source