International safety notice

Defibrillator - Cardioverter

Brazil / Anvisa · BRA · Oct 24, 2016

Key facts

Title Defibrillator - Cardioverter
Regulator Brazil / Anvisa
Country BRA
Brand The Field Action affects five products registered in Brazil: FORTIFY - Registration 10332340305 UNIFY – Registro 10332340299 Fortify Assura VR Registration 10332340358 Unify Assura – Registro 10332340344 Quadra Assura Implantable Cardioverter and Defibrillator Registration 10332340343
Manufacturer EMPRESA DETENTORA DO REGISTRO ST JUDE MEDICAL BRASIL LTDA CNPJ 00986846000142 RUA ITAPEVA 538 5º AO 8º ANDARES SÃO PAULOSP FABRICANTE ST JUDE MEDICAL SYLMAR CALIFORNIA 15900 VALLEY VIEW COURT SYLMAR CALIFORNIA 91342 ESTADOS UNIDOS
Models 10332340305, 10332340343, 10332340358, 10332340344, 10332340299
Date Oct 24, 2016
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice

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