Events

Alerta De Seguridad para GO BED HOSPITAL BED - Model FL28EX - Record 80005430271 - Lots Affected - see attachment. http://en.wikipedia.org/w/eng/index.php/

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Stryker do Brasil 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
    1210
  • Fecha
    2012-12-06
  • 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
    Stryker has received complaints regarding scales and / or bedding systems for the Go Bed Bed - mod. FL28EX, with scale or bed output (Chaperone). This unit was manufactured between March 1, 2002 and June 30, 2008. Their investigation identified that the reported problems could be attributed to the malfunctioning of charge cells. See more information in the attached Letter of Attachment. #### Update (02/01/2013): field action closed on 12/27/2012 by the record holder.
  • Causa
    Malfunction of load cells.
  • Acción
    See attached letter. http://en.wikipedia.org/w/eng/index.php

Device

GO BED HOSPITAL BED - Model FL28EX - Record 80005430271 - Lots Affected - see attachment. http://...

Manufacturer

Stryker do Brasil Ltda.
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    ANVSANVISA