Events

Alerta De Seguridad para Beds, electric. Electric bed junction box. Beds manufactured from August 1, 1998 until October 31, 2000.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Invacare Corp.

¿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
    339
  • Fecha
    2001-10-24
  • 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
    A component located inside the junction box attached to the feet of the above beds may fail and, in very rare cases, may cause the junction box to overheat. the manufacturer commenced the correction with a letter dated august 31, 2001.
  • Acción
    Verify receipt of the letter dated August 31, 2001 from Invacare. Identify and isolate all products in your inventory. If your facility has not been contacted, please contact your vendor for details on how to order the new components and install them. For more information, contact your local representative or directly with Invacare at 1 (440) 329-6000 in the United States.

Device

Beds, electric. Electric bed junction box. Beds manufactured from August 1, 1998 until October 31...

Manufacturer

Invacare Corp
  • Source
    ANVSANVISA