Events

Alerta De Seguridad para Allura Xper Angiography Equipment Technical Name: Angiography Equipment ANVISA Registration Number: 10216710153 Hazard Class: III Model Affected: ALLURA XPER FD10 OR table; ALLURA XPER FD20 OR table; ALLURA XPER FD10 (ground); ALLURA XPER FD10 (ceiling); ALLURA XPER FD20 (ground); ALLURA XPER FD20 (ceiling) Serial numbers affected: 01H025418

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
    2191
  • Fecha
    2016-12-19
  • 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
    If, after receiving the "Fluoroscopy / Exposure canceled, try again" message, repeat fluoroscopy or exposure is unsuccessful, the system must be restarted with a cold or warm restart. If a cold or hot restart is unsuccessful, contact your local Philips dealer.
  • Causa
    With the velara generator with an old firmware version, after receiving the message "fluoroscopy / exposure canceled, try again" try to repeat the fluoroscopy or the exposure will not be successful and the system will be blocked. the system lock can only be solved by resetting the system hot or cold. in exceptional cases, the velara generator will be damaged and the system can not be restarted.
  • Acción
    Field Action Code 2016-IGTBST-006 triggered under the responsibility of the company Philips Medical Systems Ltda. Company will make correction in the field.

Device

Allura Xper Angiography Equipment Technical Name: Angiography Equipment ANVISA Registration Numbe...

Manufacturer

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