International safety notice

Alert 2683 (Technovigilance) - Medtronic Comercial Ltda - Imaging Diagnostic System - Installation of software (SW) version 3.1.7 in order to solve various problems.

Brazil / Anvisa · BRA · Sep 26, 2018

Key facts

Title Alert 2683 (Technovigilance) - Medtronic Comercial Ltda - Imaging Diagnostic System - Installation of software (SW) version 3.1.7 in order to solve various problems.
Regulator Brazil / Anvisa
Country BRA
Brand Trade Name: Diagnostic Imaging System Technical Name: Surgical arc ANVISA registration number: 10339190302 Risk Class: III Affected model: O-arm 1000 Affected serial numbers: 196;
Manufacturer EMPRESA DETENTORA DO REGISTRO MEDTRONIC COMERCIAL LTDA CNPJ 01772798000152 AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR CEP 04675010 SÃO PAULO SP TEL 11 21829200 EMAIL TECNOVIGILANCIACOVIDIENCOM FABIOLACAPPELLARIMEDTRONICCOM FABRICANTE DO PRODUTO MEDTRONIC NAVIGATION INC 300 FOSTER STREET LITTLETON MA 01460 ESTADOS UNIDOS
Models 10339190302
Date Sep 26, 2018
Regulator page anvisa.gov.br

At a glance

  • No Recall
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