International safety notice
Technical name: SURGICAL NAVIGATION SYSTEM
Brazil / Anvisa · BRA · Mar 20, 2017
Key facts
| Title | Technical name: SURGICAL NAVIGATION SYSTEM |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: EP NAVIGATION SYSTEM - CARTO 3 System Technical name: SURGICAL NAVIGATION SYSTEM ANVISA registration number: 80145901192 Risk class: III Affected model: CARTO 3 System Affected serial numbers: SKU FG540000 and FG540000U |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO JOHNSON JOHNSON DO BRASIL IND E COM DE PROD PARA SAÚDE LTDA CNPJ 54516661000101 LOCALIZADA NA AV JUSCELINO KUBITSCHEK Nº 2041 ANDARES 8º E 9º COMPLEXO JK BLOCO B SÃO PAULO SP FABRICANTE BIOSENSE WEBSTER INC 3333 DIAMOND CANYON ROAD DIAMOND BAR CA 91765 USA E BIOSENSE WEBSTER ISRAEL LTD 4 HATNUFA STREET PO BOX 275 YOKNEAM 20692 ISRAEL |
| Models | 80145901192, FG540000U, FG540000 |
| Date | Mar 20, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
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