International safety notice

Alert 2580 (Technosurveillance) - Cardiopulmonary Maquet.

Brazil / Anvisa · BRA · May 30, 2018

Key facts

Title Alert 2580 (Technosurveillance) - Cardiopulmonary Maquet.
Regulator Brazil / Anvisa
Country BRA
Brand Trade Name: Intra-Aortic Balloon Pump Technical Name: Balao Intra-Aortic Pump System ANVISA registration number: 10390690062 Risk Class: III Affected model: CARDIOSAVE Affected serial numbers: CH207880C5;
Manufacturer EMPRESA DETENTORA DO REGISTRO MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA CNPJ 00944324000188 AV MARGINAL DO RIBEIRAO DOS CRISTAIS 500 CAJAMAR SP TEL 1126087387 EMAIL GUILHERMEPACINIGETINGECOM FABRICANTE DO PRODUTO DATASCOPE CORP 1300 MACARTHUR BLVD MAHWAH NJ 07430 ESTADOS UNIDOS DA AMÉRICA
Models CH245699K6, CH207880C5, 10390690062
Date May 30, 2018
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice

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