International safety notice

Alert 2282 Updated (Technosurveillance) Siemens - Digital Mammography Device - Biopsy functionality blocked

Brazil / Anvisa · BRA · Apr 27, 2017

Key facts

Title Alert 2282 Updated (Technosurveillance) Siemens - Digital Mammography Device - Biopsy functionality blocked
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: Digital Mammography Device Technical name: Mammography Device ANVISA registration number: 10345162027 Product type: Equipment Risk class: III Affected model: MAMMOMAT Inspiration Affected serial numbers (updated list): 8001; Access the full content of Alert 2282 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas).
Manufacturer EMPRESA DETENTORA DO REGISTRO SIEMENS HEALTHCARE DIAGNÓSTICOS SA CNPJ 01449930000190 ENDEREÇO AV MUTINGA 3800 7º ANDAR PIRITUBA SÃO PAULOSP TELEFONE 0800 129 633 FABRICANTE SIEMENS AG WITTELSBACHERPLATZ 2 DE80333 MUENCHEN ALEMANHA
Models 10345162027
Date Apr 27, 2017
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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