Events

Alerta De Seguridad para NITROGEN MONITORS / LOCATOR / NERVE STIMULATORS NUMBERS FJ960184, 120, 132, 134, 137, 142, 144, 166, 0001-1014, 0003-1015, 9909-1001, 9910-1000, 9910-1002, 9910-1005, 9910-1006, 9910-1007, 9911-1008, 9911-1009, 9911-1011, 9912-1012, 9912-1013

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por NEUROSOFT 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
    28
  • Fecha
    2001-05-14
  • 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
    The electrical safety of the above monitors does not comply with international standards as declared in the marketing registry. neurosoft declares that the potential of electrical shock on the operator or patient is increased. the level of gravies.
  • Acción
    THE MANUFACTURER STARTED WITHDRAWN IN. VERIFY THAT YOU HAVE RECEIVED THE NEUROSOFT LETTER OF OCTOBER 20, 2000. IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. REPORT USERS AND MAINTENANCE MANAGERS IN YOUR ESTABLISHMENT OF THE ALERT WITH THESE MONITORS AND DO NOT USE THEM. NEUROSOFT MUST REPLACE THEM BY MONITORS CONFORMING TO THE RULES. IF YOU ARE SUSPECTED THAT THERE WERE AGGRAVATIONS ASSOCIATED WITH THE USE OF YOUR A3000 SYSTEM, CONTACT THE NEUROSOFT TECHNICAL OFFICER BY PHONE 0021-1-703-904-7875. NEUROSOFT MUST AGENDE THE REPLACEMENT OF COMPONENTS NOT CONFORMING TO YOUR ESTABLISHMENT.

Device

NITROGEN MONITORS / LOCATOR / NERVE STIMULATORS NUMBERS FJ960184, 120, 132, 134, 137, 142, 144, 1...

Manufacturer

NEUROSOFT INC.
  • Source
    ANVSANVISA