International safety notice
Alert 2454 (Technosurveillance) - Boston - Defibrillator for MRI Cardiac Resynchronization Therapy Problem: minimum ventilation sensor signal failure
Brazil / Anvisa · BRA · Dec 28, 2017
Key facts
| Title | Alert 2454 (Technosurveillance) - Boston - Defibrillator for MRI Cardiac Resynchronization Therapy Problem: minimum ventilation sensor signal failure |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: MRI Cardiac Resynchronization Therapy Defibrillator Technical name: Implantable Defibrillator for Cardiac Resynchronization Therapy ANVISA registration number: 10341350823 Risk class: IV Affected model: U125; Affected serial numbers: See attached list |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BOSTON SCIENTIFIC DO BRASIL LTDA CNPJ 01513946000114 AV DAS NAÇÕES UNIDAS 21476 EDIFÍCIOS P8 P9 E P10 VILA ALMEIDA SÃO PAULO SP FABRICANTE BOSTON SCIENTIFIC LIMITED CASHEL ROAD CLONMEL CO TIPPERARY IRLANDA ESTADOS UNIDOS TELEFONE 11 43808748 EMAIL REGULATORIOBSCICOM |
| Models | 10341350823 |
| Date | Dec 28, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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