International safety notice
Alert 2679 Updated (Technosurveillance) - Auto Suture do Brasil Ltda - BIS Monitoring System Possibility of short circuit in old batteries.
Brazil / Anvisa · BRA · Sep 21, 2018
Key facts
| Title | Alert 2679 Updated (Technosurveillance) - Auto Suture do Brasil Ltda - BIS Monitoring System Possibility of short circuit in old batteries. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: BIS Monitoring System Technical Name: Electroencephalograph ANVISA registration number: 10349000393 Risk Class: II Affected model: BIS Complete Monitoring System Affected serial numbers: See attached distribution list Update: Alert 3015 informs a new phase of the action described in this Alert 2679. Access the full content of Alerts 3015 and 2679 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas). |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO AUTO SUTURE DO BRASIL LTDA CNPJ 01645409000128 AV JORNALISTA ROBERTO MARINHO 85 11º ANDAR CEP 04675010 SÃO PAULO SP TEL 11 21829200 EMAIL TECNOVIGILANCIACOVIDIENCOMFABIOLACAPPELLARIMEDTRONICCOM FABRICANTE DO PRODUTO COVIDIEN LLC 15 HAMPSHIRE STREET MANSFIELD MA 02048 ESTADOS UNIDOS |
| Models | 10349000393 |
| Date | Sep 21, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
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About International device safety notices
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