International safety notice

Technical Name: Vital Signs Monitor

Brazil / Anvisa · BRA · Jun 16, 2016

Key facts

Title Technical Name: Vital Signs Monitor
Regulator Brazil / Anvisa
Country BRA
Brand Commercial Name: EV1000A - INTENSIVE CARE MONITOR (Vital Signs Monitor) / model EV1000A/registration 80219050127/risk class III-High Risk//Affected series: attached document.
Manufacturer DADOS DO DETENTOR DO REGISTRO NO BRASIL EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICOCIRÚRGICOS LTDA RUA VERBO DIVINO 15471ºANDAR FONE 11 55675233 EMAIL CORABELZONIEDWARDSCOM FABRICANTE EDWARDS LIFESCIENCES LLC ONE EDWARDS WAY IRVINE CALIFORNIA 926145686ESTADOS UNIDOS
Models EV1000A, 80219050127
Date Jun 16, 2016
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data
  • 1–9 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

Browse all International device safety notices