Events

Alerta De Seguridad para BD PHOENIX SYSTEM SOFTWARE and BD PHOENIX UPDATE DISKS (PUD), BD PHOENIX SYSTEM equipment accessories. Anvisa Registry n ° 10033430436.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Becton Dickinson Indústrias Cirúrgicas 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
    1126
  • Fecha
    2012-04-19
  • 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
    Check information presented by the company in the alert message to the user, available at http://portal.anvisa.gov.br/wps/wcm/connect/5dae6d004af1e491820fafa337abae9d/Alerta_1126_Messagem_de_alerta.pdf?MOD=AJPERES
  • Causa
    The software algorithm may lead to an incorrect interpretation of the result, falsely indicating that strains of enteroccocus faecium are susceptible to the antibiotic vancomycin.
  • Acción
    Becton Dickinson Ltda has already started the field action (software update) with its customers and distributors in Brazil. Until the software update is performed by the company, it is suggested to read the company recommendations to the users of the product - the recommendations are detailed in the User Alert Message sent by the company to its customers and available at http: // portal .anvisa.gov.br / wps / wcm / connect / 5dae6d004af1e491820fafa337abae9d / Alert_1126_Message_of_alerta.pdf? MOD = AJPERES

Device

BD PHOENIX SYSTEM SOFTWARE and BD PHOENIX UPDATE DISKS (PUD), BD PHOENIX SYSTEM equipment accesso...

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda
  • Source
    ANVSANVISA