International safety notice
Technical name: Vital Signs Monitor
Brazil / Anvisa · BRA · Oct 18, 2016
Key facts
| Title | Technical name: Vital Signs Monitor |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: EP Navigation System - CARTO 3 System Technical name: Vital Signs Monitor ANVISA registration number: 80145901192 Risk class: III Affected model: CARTO 3 System Affected serial numbers: SKU:FG540000 | |
| 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 ISRAEL LTD LOCALIZADA NA 4 HATNUFA STREET PO BOX 275 YOKNEAM 20692 ISRAEL E BIOSENSE WEBSTER INC LOCALIZADA NA 3333 DIAMOND CANYON ROAD DIAMOND BAR CA 91765 |
| Models | 50203, 11567, 80145901192, 14528, 50531, 14718, 14218, 50573, FG540000, 13173, 13213, 13208 |
| Date | Oct 18, 2016 |
| 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