Events

Alerta De Seguridad para Generators of Radio-Frequency Model 4810. UPN. M00448100

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Boston Scientific/EP Technologies.

¿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
    552
  • Fecha
    2000-03-01
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    An ecri member hospital reported that there was a failure of communication between the micro-electronic program components in the above radio-frequency generators. this communication failure puts the device in fail-safe mode, rendering it inoperative. the manufacturer states that this problem began on january 2, 2002. the manufacturer initiated a correction for a notification during the week of january 7, 2002 by federal express.
  • Acción
    Verify that you received the January 2002 Boston Scientific Correction Notice. Identify and isolate any affected product in your inventory. If your unit (s) has not received coverage from this service, please contact your EP Technologies sales representative, who will put you in touch with the appropriate person at Boston Scientific. For more information, contact Boston Scientific / EP Technologies in the USA by phone at (1408) 895-3626, or your local representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Generators of Radio-Frequency Model 4810. UPN. M00448100

Manufacturer

Boston Scientific/EP Technologies
  • Source
    ANVSANVISA