International safety notice

Technical name: Endoscopy System

Brazil / Anvisa · BRA · Dec 21, 2017

Key facts

Title Technical name: Endoscopy System
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: Digital Spyglass System Technical name: Endoscopy System ANVISA registration number: 10341350849 Risk class: II Affected model: M00546600 Affected serial numbers: 21071349;
Manufacturer EMPRESA DETENTORA DO REGISTRO BOSTON SCIENTIFIC DO BRASIL LTDA CNPJ 01513946000114 AV DAS NAÇÕES UNIDAS 21476 EDIFÍCIOS P8 P9 E P10 VILA ALMEIDA SÃO PAULO SP FABRICANTE BOSTON SCIENTIFIC CORPORATION ENERCON TECHNOLOGIES 780 BROOKSIDE DRIVEINDIANA 47460EUA 25 NORTHBROOK DRIVE PO BOX 665GRAYME 04039EUA ESTADOS UNIDOS EMAIL REGULATORIOBSCICOM
Models 21186002, 21207916, 21215249, 21129863, 21180343, M00546600, 10341350849, 21071349, 21139834, 21186874, 21196427
Date Dec 21, 2017
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models 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

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