International safety notice
Alert 2542 (Technosurveillance) - Maquet - Rolite Volista Standop Surgical Focus Possibility of device keyboard failure.
Brazil / Anvisa · BRA · Apr 17, 2018
Key facts
| Title | Alert 2542 (Technosurveillance) - Maquet - Rolite Volista Standop Surgical Focus Possibility of device keyboard failure. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Rolite Volista Standop Surgical Focus Technical name: Surgical Focus ANVISA registration number: 80259110090 Risk class: I Affected model: Rolite Volista 400; Affected serial numbers: All VOLISTA StandOP/TRIOP domes, manufactured until 06/2017 and equipped with the ARD568801560 keyboard. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MAQUET DO BRASIL EQUIPAMENTOS MEDICOS LTDA CNPJ 06028137000130 RUA TENENTE ALBERTO SPICCIATI 200 SÃO PAULO SP TEL 11 26087387 EMAIL GUILHERMEPACINIGETINGECOM FABRICANTE MAQUET SAS PARC DE LIMÈRE AVENUE DE LA POMME DE PIN CS 10008 ARDON 45074 ORLEANS CEDEX 2 TELEFONE 33 02 38 25 88 86 E MAIL COMPLAINTSARDONQRCGETINGECOM |
| Models | ARD568801560, 80259110090 |
| Date | Apr 17, 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