International safety notice

Alert 2756 (Technosurveillance) - Dräger Indústria e Comércio Ltda - JM-105 Jaundice Meter - Jaundice Meter firmware update.

Brazil / Anvisa · BRA · Dec 28, 2018

Key facts

Title Alert 2756 (Technosurveillance) - Dräger Indústria e Comércio Ltda - JM-105 Jaundice Meter - Jaundice Meter firmware update.
Regulator Brazil / Anvisa
Country BRA
Brand Trade Name: JM-105 Jaundice Meter Technical Name: Skin Color Meter ANVISA registration number: 10407379016 Risk Class: II Affected model: JM-105 Jaundice Meter Affected serial numbers: See attachment List of serial numbers
Manufacturer EMPRESA DETENTORA DO REGISTRO DRÄGER INDÚSTRIA E COMÉRCIO LTDA CNPJ 02535707000128 ALAMEDA PUCURUÍ 51 TAMBORÉ BARUERI SP TEL 11 46894415 EMAIL DENISESOUZADRAEGERCOM FABRICANTE DO PRODUTO KONICA MINOLTA OPTICS INC JAPÃO LOCAL DE FABRICAÇÃO DRÄGER MEDICAL SYSTEMS INC LEGAL 3135 QUARRY ROAD TELFORD PA 189691042 EUA
Models JM-105, 10407379016
Date Dec 28, 2018
Regulator page anvisa.gov.br

At a glance

  • No Recall
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