International safety notice

Technical name: Defibrillator

Brazil / Anvisa · BRA · Jan 26, 2018

Key facts

Title Technical name: Defibrillator
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: HeartStart MRx Defibrillator Technical name: Defibrillator ANVISA registration number: 10216710136 Risk class: III Affected model: M3535A, M3536A Affected serial numbers: US00205374;
Manufacturer EMPRESA DETENTORA DO REGISTRO PHILIPS MEDICAL SYSTEMS LTDA CNPJ 58295213000178 AV TAMBORÉ 14001440 BOX 31 A 33 TAMBORÉ BARUERI SP FABRICANTE PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN ROAD ANDOVER MA 018101099 ESTADOS UNIDOS EMAIL REGULATORIOSPHILIPSCOM
Models US00579421, US00576585, 10216710136, US00579503, US00584388, US00579425, US00576602, US00576606, M3535A, US00579408, US00576597, US00569420 and 98 more
Date Jan 26, 2018
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 10–99 Matching device models in FDA data
  • 10–99 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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