International safety notice
Alert 2796 (Technovigilance) - Medstar Importação e Exportação Eireli - SONATATI100 Cochlear Implant - Units do not comply with the helium leak test specifications.
Brazil / Anvisa · BRA · Feb 8, 2019
Key facts
| Title | Alert 2796 (Technovigilance) - Medstar Importação e Exportação Eireli - SONATATI100 Cochlear Implant - Units do not comply with the helium leak test specifications. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: SONATATI100 Cochlear Implant Technical Name: Hearing Implants ANVISA registration number: 80047300679 Risk Class: IV Affected model: SONATA TI100 + STANDARD Affected serial numbers: SONATA TI100 + STANDARD. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO EIRELI CNPJ 03580620000135 RUA VALÊNCIO SOARES RODRIGUES 89 SALA 1 CENTRO VARGEM GRANDE PAULISTA SP TEL 11 50923700 EMAIL JFMENEZESMEDSTARCOMBR FABRICANTE DO PRODUTO FABRICANTE E DISTRIBUIDOR MEDEL ELEKTROMEDIZINISCHE GERATE GMBH FURSTENWEG 77A INNSBRUCK 6020 ÁUSTRIA |
| Models | TI100, SONATATI100, 80047300679, 164324 |
| Date | Feb 8, 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