International safety notice

Alert 2669 (Technosurveillance) Update System.

Brazil / Anvisa · BRA · Sep 13, 2018

Key facts

Title Alert 2669 (Technosurveillance) Update System.
Regulator Brazil / Anvisa
Country BRA
Brand Trade Name: Ysio X-Ray System. Technical Name: Fluoroscopic X-ray System. ANVISA registration number: 10345162022. Risk Class: III Affected models and serial numbers: Ysio (23706, 23620). Trade Name: Axiom Multix Digital Radiography System. Technical Name: Digital Radiography System. ANVISA registration number: 10234230143. Risk Class: III. Affected models and serial numbers: AXIOM Luminos dRF (3252, 4248, 4255, 4368, 4664); Commercial Name: Multix Fixed Radiological Set. Technical Name: Fixed Radiological Set. Registration number: 10234230077. Risk Class: III. Affected models and serial numbers: MULTIX TOP (2856, 2853);
Manufacturer EMPRESA DETENTORA DO REGISTRO SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA CNPJ 01449930000190 AV MUTINGA 3800 4º E 5º ANDAR PIRITUBA SÃO PAULO SP TEL 11 39081649 EMAIL JAQUELINESANTOSSIEMENSHEALTHINEERSCOM FABRICANTE DO PRODUTO SIEMENS HEALTHCARE GMBH SIEMENSSTRASSE1 91301 FORCHHEIM GERMANY ALEMANHA
Models 23706, 23620, 10345162022, 10234230143, 10234230077
Date Sep 13, 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

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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