International safety notice

Alert 2628 (Technovigilance) - Siemens Healthcare Diagnósticos Ltda - Artis Angiography Equipment Possibility of overloading the x-ray generator if a short circuit occurs in the x-ray ampoule.

Brazil / Anvisa · BRA · Jul 26, 2018

Key facts

Title Alert 2628 (Technovigilance) - Siemens Healthcare Diagnósticos Ltda - Artis Angiography Equipment Possibility of overloading the x-ray generator if a short circuit occurs in the x-ray ampoule.
Regulator Brazil / Anvisa
Country BRA
Brand Trade Name: Artis Angiography Equipment Technical Name: Angiography Equipment ANVISA registration number: 10345162023 Risk Class: III Affected model: Artis Q ceiling; Affected serial numbers: 109430;
Manufacturer EMPRESA DETENTORA DO REGISTRO SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA AV MUTINGA 3800 4º E 5º ANDAR PIRITUBA SÃO PAULO SP TEL 11 39082132 EMAIL FELIPEDEMELOFARIASIEMENSHEALTHINEERSCOM FABRICANTE DO PRODUTO SIEMENS HEALTHCARE GMBH SIEMENSSTR 1 91301 FORCHHEIM ALEMANHA
Models 121125, 10345162023, 109430
Date Jul 26, 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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