Events

Safety Alert for RX-10 Heart Rate Monitor,

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by TRANSMAI EQUIPAMENTOS MÉDICOS HOSPITALARES 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
    654
  • Date
    2002-08-20
  • 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
    Determine, as a measure of sanitary interest, throughout the national territory, the prohibition, suspension of sale and manufacture of the RX-10 Cardiac Monitor product, as it does not have a registration with ANVISA / MS.
  • Reason
    For not having registered with anvisa / ms.
  • Action
    To determine, as a measure of sanitary interest, throughout the national territory, the prohibition, suspension of sale and manufacture of the product RX-10 Cardiac Monitor

Device

RX-10 Heart Rate Monitor,

Manufacturer

TRANSMAI EQUIPAMENTOS MÉDICOS HOSPITALARES LTDA
  • Source
    ANVSANVISA