International safety notice
Alert 2849 (Technosurveillance) - Boston Scientific do Brasil Ltda - Auriga Laser System Possibility that consoles exhibit power degradation faster than normal due to cooling problems.
Brazil / Anvisa · BRA · Apr 16, 2019
Key facts
| Title | Alert 2849 (Technosurveillance) - Boston Scientific do Brasil Ltda - Auriga Laser System Possibility that consoles exhibit power degradation faster than normal due to cooling problems. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Auriga Laser System Technical Name: Laser Therapy System ANVISA registration number: 10341350932 Risk Class: III Affected model: Auriga 30 (M006830B0) and Auriga XL 4007 (M0068F4007B0) Affected serial numbers: 21302770; |
| 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 TEL 11 43808706 EMAIL REGULATORIOBSCICOM FABRICANTE DO PRODUTO BOSTON SCIENTIFIC CORPORATION 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 ESTADOS UNIDOS |
| Models | 21302966, 21302784, 21302930, 21302803, 21303016, 21303021, M006830B0, 21302772, M0068F4007B0, 21302968, 21302985, 21302770 and 3 more |
| Date | Apr 16, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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