International safety notice
Alert 2647 (Technovigilance) - Emergo Brazil Import Importação e Distribuição de Produtos Médicos Hospitalares Ltda - EOS Imaging - Possibility of problems at the sterEOS image review station.
Brazil / Anvisa · BRA · Aug 15, 2018
Key facts
| Title | Alert 2647 (Technovigilance) - Emergo Brazil Import Importação e Distribuição de Produtos Médicos Hospitalares Ltda - EOS Imaging - Possibility of problems at the sterEOS image review station. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Stereos Workstation Technical Name: Software ANVISA registration number: 80117580285 Risk Class: II Affected model: sterEOS Workstation Affected serial numbers: 41,612,604 and 41,612,603 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO EMERGO BRAZIL IMPORT IMPORTAÇÃO E DISTRIBUIÇÃO DE PRODUTOS MÉDICOS HOSPITALARES LTDA CNPJ 04967408000198 AV FRANCISCO MATARAZZO 1752 SALA 502 SALA 503 AGUA BRANCA CEP 05001200 SÃO PAULOSP SÃO PAULO SP TEL 11 38011181 EMAIL LUIZLEVYULCOM FABRICANTE DO PRODUTO EOS IMAGING 10 RUE MERCOEUR 75011 PARIS FRANÇA |
| Models | 80117580285, 41.612.604, 41.612.603 |
| Date | Aug 15, 2018 |
| 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