International safety notice

Technical name: Surgical Focus

Brazil / Anvisa · BRA · Dec 1, 2017

Key facts

Title Technical name: Surgical Focus
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: Synchromed II Implantable Infusion Pump Technical name: Surgical Focus ANVISA registration number: 80259119002 Risk class: I Affected model: HLX 3004-3005 Affected serial numbers: Vertical connection of Acrobat 2000 articulated arms, manufactured between 2004 and 2006, equipping the HLX 2004-2005, HLX 3004-3005 and XTEN surgical lights.
Manufacturer EMPRESA DETENTORA DO REGISTRO MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA CNPJ 06028137000130 RUA TENENTE ALBERTO SPICCIATI 200 SÃO PAULO SP FABRICANTE MAQUET SAS AVENUE DE LA POMME DE PIN 45074 ORLÉANS FRANÇA TELEFONE 33 0 7 61 94 52 39 EMAIL ANURUDDHIKAWANASINGHEGETINGECOM
Models 80259119002, 2004-2005, 3004-3005
Date Dec 1, 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

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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