Events

Safety Alert for BD PHOENIX SYSTEM SOFTWARE and BD PHOENIX UPDATE DISKS (PUD), BD PHOENIX SYSTEM equipment accessories. Anvisa Registry n ° 10033430436.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Becton Dickinson Indústrias Cirúrgicas Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1126
  • Date
    2012-04-19
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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
  • Reason
    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.
  • Action
    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