International safety notice
Alert 2806 (Technosurveillance) - Medtronic - StealthStation S7 System and Stealthstation i7 Surgical Navigation System - New information about the problem and additional recommendations related to field action code FA 848.
Brazil / Anvisa · BRA · Mar 8, 2019
Key facts
| Title | Alert 2806 (Technosurveillance) - Medtronic - StealthStation S7 System and Stealthstation i7 Surgical Navigation System - New information about the problem and additional recommendations related to field action code FA 848. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: StealthStation S7 System; Technical Name: Surgical Navigation System ANVISA registration number: 10339190361; Risk Class: III Affected model: Not applicable Affected serial numbers: N04131056; |
| 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 300 FOSTER STREET LITTLETON MA 01460 ESTADOS UNIDOS |
| Models | N06245893, N04108688, N03041573, N07330801, N04128564, N07521376, N04241189, N07330750, N04175028, N06245894, N06248803, 10339190612 and 8 more |
| Date | Mar 8, 2019 |
| 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