International safety notice
Alert 2704 (Technosurveillance) - Medtronic Comercial Ltda - O´Arm 2 Mobile Imaging System - Software update with the aim of correcting abnormalities in the previous version that could cause injury.
Brazil / Anvisa · BRA · Oct 23, 2018
Key facts
| Title | Alert 2704 (Technosurveillance) - Medtronic Comercial Ltda - O´Arm 2 Mobile Imaging System - Software update with the aim of correcting abnormalities in the previous version that could cause injury. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: O´Arm 2 Mobile Imaging System Technical Name: Mobile X-ray Device ANVISA registration number: 10339190638 Risk Class: III Affected model: O-arm O2 Affected serial numbers: C1389; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MEDTRONIC COMERCIAL LTDA CNPJ 01772798000152 AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR CEP 04675010 SÃO PAULO SP TEL 11 21829200 EMAIL TECNOVIGILANCIACOVIDIENCOM FABIOLACAPPELLARIMEDTRONICCOM FABRICANTE DO PRODUTO MEDTRONIC NAVIGATION INC LITTLETON 300 FOSTER STREET LITTLETON MA 01460 ESTADOS UNIDOS |
| Models | 10339190638, C1482, C1389 |
| Date | Oct 23, 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