Events

Alerta De Seguridad para Combination of the STEALTHSTATION S7 SYSTEM + Berchtold F-Generation LED Lamps. Antenna Register (S7 STEALTHSTATION S7) n ° 10339190361. Affected series of Berchtold F-Generation LED lamps: Lamps F528 with serial number LESS than 831800001526 and Lamps F628 with serial number LESS than 831710002819.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC COMERCIAL LTDA.; MEDTRONIC NAVIGATION INC.

¿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
    1455
  • Fecha
    2014-11-10
  • 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
    When the lamps are positioned according to the Berchtold Instructions for Use - at a distance of at least one meter from the patient - there is no interference. When the lamps are positioned closer to the patient, the resulting EMI causes the StealthStation® AxiEM ™ or Fusion EM system to no longer track and display the "red status", which prevents navigation until the EMI is eliminated.
  • Causa
    Possibility of electromagnetic interference (emi) in the stealthstation s7 system, generated by the use of the berchtold f-generation lamps.
  • Acción
    Carefully follow the instructions for use of the product, paying attention to the minimum distance of 1 meter that must be maintained between the lamp and the patient. Check the Medtronic Alert Message at: http://portal.anvisa.gov.br/wps/wcm/connect/39253000462a0900b972bfec1b28f937/Carta+ao+Cliente.pdf?MOD=AJPERES

Device

Combination of the STEALTHSTATION S7 SYSTEM + Berchtold F-Generation LED Lamps. Antenna Register ...

Manufacturer

MEDTRONIC COMERCIAL LTDA.; MEDTRONIC NAVIGATION INC
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA