International safety notice

Technical name: X-ray Fluoroscopic System

Brazil / Anvisa · BRA · Apr 20, 2017

Key facts

Title Technical name: X-ray Fluoroscopic System
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: AXIOM ICONOS X-Ray System Technical name: Fluoroscopic X-Ray System ANVISA registration number: 10234230063 Risk class: III Affected model: R100, R200 Affected serial numbers: 4603, 10021, 10024, 10025, 10026, 10034, 10039, 10053, 10219, 10243, 10244, 11000, 11003, 11018, 11101, 11113, 12005, 12018, 12111, 12132, 12133, 12192, 12 194, 12215, 12223, 12401, 12403, 12405, 12406
Manufacturer EMPRESA DETENTORA DO REGISTRO SIEMENS HEALTHCARE DIAGNÓSTICOS SA CNPJ 01449930000190 ENDEREÇO AV MUTINGA 3800 7º ANDAR PIRITUBA SÃO PAULOSP FABRICANTE SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD 278 ZHOU ZHU ROAD SHANGAI 201318 CHINA
Models 12215, 12018, 10021, 11003, 12401, 10034, 12133, 11000, 12403, 10024, 12406, 12223 and 17 more
Date Apr 20, 2017
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 100–999 Matching device models in FDA data
  • 100–999 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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