International safety notice

Technical name: Fixed X-ray Device

Brazil / Anvisa · BRA · Dec 3, 2016

Key facts

Title Technical name: Fixed X-ray Device
Regulator Brazil / Anvisa
Country BRA
Brand Commercial name: PRESTIGE II X-RAY SYSTEM Technical name: Fixed X-ray Apparatus ANVISA registration number: 80071260010 Risk class: III Affected model: Prestige II Affected serial numbers: PRESTIGE II ANVISA: 80071260010);
Manufacturer EMPRESA DETENTORA DO REGISTRO GE HEALTHCARE DO BRASIL COM E SERV PARA EQUIPAMENTOS MÉDICOHOSPITALARES LTDA ENDEREÇO AV MAGALHÃES DE CASTRO Nº 4800 13º ANDAR CIDADE JARDIM SP TELEFONE 11 30678436 FABRICANTE GE HEALTHCARE PAÍS ESTADOS UNIDOS ENDEREÇO 3030 OHMEDA DRIVE MADISON WI
Models 10310650033, 80071260060, 10310650031, 10310650014, 80071260010, 10310650029
Date Dec 3, 2016
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 10–99 Matching device models in FDA data
  • 10–99 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

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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