International safety notice
Technical name: EVHRS Cardiac Reference Sensor
Brazil / Anvisa · BRA · Dec 21, 2017
Key facts
| Title | Technical name: EVHRS Cardiac Reference Sensor |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome comercial: Clearsight Technical name: EVHRS Cardiac Reference Sensor ANVISA registration number: 80219050157 Risk class: III Affected model: EVHRS Affected serial numbers: 600104021640; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICOCIRÚRGICOS LTDA ED RUA VERBO DIVINO 1547 1º ANDAR CJS 101102 SP TEL 1155675233 FABRICANTE EDWARDS LIFESCIENCES LLC ONE EDWARDS WAY IRVINE CALIFORNIA 926145686 ESTADOS UNIDOS TEL 1155675200 |
| Models | 600104011085, 600104011091, 600104011084, 600104011078, 600104011081, 600104011088, 600104021642, 600104011080, 600104021640, 80219050157, 600104011087 |
| Date | Dec 21, 2017 |
| 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