Events

Alerta De Seguridad para X-ray Systems for Brilliance Computed Tomography. Anvisa Record: 10216710191. Potentially Affected Models: Brilliance 6, 10, 16, 16P, 40, 64, Big Bore, iCT, iCT SP.

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.

¿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
    1057
  • Fecha
    2011-04-27
  • 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 the problem is identified, a Mandatory Safety Modification Order to repair the vertical braking center on the patient's desk will be issued by Philips, free of charge. The Safety Service Engineer will perform a rework of the system's braking center to solve the problem. If any additional information or support is required regarding this matter, contact your local Philips representative or Philips local health office - Customer Service Solutions Center (Tel .: 0800-701-77-89). Additional information can be found at http://portal.anvisa.gov.br/wps/wcm/connect/1773018046a71ce891fe95c9c474c85c/Carta+a++clients.pdf?MOD=AJPERES
  • Causa
    Failure in the vertical bracket of the patient bracket can cause the equipment table to break.
  • Acción
    If a failure of this type is observed, the system should no longer be used and the product registration holder (Philips Medical System Ltda.), Or its nearest representative, should be notified of the problem.

Device

X-ray Systems for Brilliance Computed Tomography. Anvisa Record: 10216710191. Potentially Affecte...

Manufacturer

Philips Medical Systems
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA