International safety notice

Alert 2524 (Technosurveillance) Update Maquet - Servo-I Lung Ventilator, Servo-S Lung Ventilator, Sist.

Brazil / Anvisa · BRA · Mar 16, 2018

Key facts

Title Alert 2524 (Technosurveillance) Update Maquet - Servo-I Lung Ventilator, Servo-S Lung Ventilator, Sist.
Regulator Brazil / Anvisa
Country BRA
Brand Commercial Name: Servo-I Lung Ventilator (80259110006), Servo-S Lung Ventilator (80259110034), Ventilation System (80259110072) Servo-u and Servo-n model, Servo-air Ventilation System (80259110124) Technical Name: Pressure and Volume Ventilator ANVISA registration number: 80259110006, 80259110034, 80259110072, 80259110124. Product type: Equipment Risk Class: Class III Affected serial numbers: See updated list Access the full content of Alert 2524 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas).
Manufacturer EMPRESA DETENTORA DO REGISTRO MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA CNPJ 06028137000130 RUA TENENTE ALBERTO SPICCIATI 200 SÃO PAULO SP FABRICANTE MAQUET CRITICAL CARE AB RÖNTGENVÄGEN 2 SE171 54 SOLNA SUÉCIA TELEFONE 46 10 335 79 81 EMAIL REGULATORYAFFAIRSMAQUETCOM
Models 80259110072, 80259110034, 80259110124, 80259110006
Date Mar 16, 2018
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

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

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