International safety notice

Alert 2483 (Technosurveillance) - Paramount - Qualitas Gama - Error in measuring the digital scale and the movement of the side rails.

Brazil / Anvisa · BRA · Feb 22, 2018

Key facts

Title Alert 2483 (Technosurveillance) - Paramount - Qualitas Gama - Error in measuring the digital scale and the movement of the side rails.
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: Qualitas Gama Technical name: Motorized Bed ANVISA registration number: 80509610013 Risk class: I Affected model: PA-66254*XS Affected serial numbers: 9010157-00003;
Manufacturer EMPRESA DETENTORA DO REGISTRO BED DO BRASIL COMÉRCIO DE EQUIPAMENTOS MÉDICOS LTDA CNPJ 08994833000127 RUA MAESTRO CARDIM 407 CJ 1007 1009 E 1010 LIBERDADE CEP01323000 SÃO PAULO SP FABRICANTE PARAMOUNT BED CO LTD 145 2CHOME HIGASHISUNA KOTOKU TOKYO 1368670 JAPÃO TELEFONE 81336482961
Models 9010088-00009, 9010088-00004, 9010157-00011, 9010088-00006, 9010088-00008, 80509610013, 9010088-00010, 9010157-00004, 9010088-00015, 9010088-00002, 9010088-00012, 9010157-00015 and 20 more
Date Feb 22, 2018
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data
  • 1–9 Matching catalog numbers 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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