International safety notice
Technical name;
Brazil / Anvisa · BRA · Jul 19, 2016
Key facts
| Title | Technical name; |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Two affected Products: 1 - IMAGEMO-arm® 1000 DIAGNOSTIC SYSTEM/Model numbers BI-700-00027 and BI-700-00028: Trade name; Technical name; Classification in the registry: EQUIPMENT ANVISA Registration No.: 10339190302 Risk Classification: Class III (High Risk) 2 - O®Arm 2 MOBILE IMAGING SYSTEM/Model number BI-700-02000 Trade name: O´Arm 2 Mobile Imaging System Technical Name: Mobile X-ray Device Classification in the registry: EQUIPMENT ANVISA Registration No.: 10339190638 Risk Classification: Class III (High Risk) |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MEDTRONIC COMERCIAL LTDA CNPJ 01772798000152 AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR CEP 04675010 SÃO PAULOSP FABRICANTE O FABRICANTE LEGAL E O FÍSICO É A MEDTRONIC NAVIGATION INC NO ENDEREÇO 300 FOSTER STREET LITTLETON MA 01460 ESTADOS UNIDOS |
| Models | BI-700-00028, BI-700-02000, BI-700-00027, 10339190302, 10339190638 |
| Date | Jul 19, 2016 |
| 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