International safety notice
Alert 2711 (Technosurveillance) - Emergo Brazil - FLEXLAB 3.6 - Possibility of interference with the functionality of pacemakers at distances close to the transport mechanism that moves the robot.
Brazil / Anvisa · BRA · Oct 29, 2018
Key facts
| Title | Alert 2711 (Technosurveillance) - Emergo Brazil - FLEXLAB 3.6 - Possibility of interference with the functionality of pacemakers at distances close to the transport mechanism that moves the robot. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: Flexlab 3.6 Technical Name: Equipment for Sample Preparation for In Vitro Diagnostics ANVISA registration number: 80117580182 Risk Class: I Affected model: Flexlab 3.6 Affected serial numbers: FLX.095 |
| 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 INPECO SPA VIA GIUSEPPE DI VITTORIO 11 20090 SEGRATE MILÃO ITÁLIA |
| Models | 80117580182, FLX.095 |
| Date | Oct 29, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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