Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by NEUROSOFT INC..

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
    28
  • Date
    2001-05-14
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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.
  • Action
    THE MANUFACTURER STARTED WITHDRAWN IN.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