International safety notice
Alert 2710 (Technovigilance) - Medtronic Comercial Ltda - Stealthstation S7 System - Stealthstation i7 Surgical Navigation System - Possibility of inaccuracy during biopsy procedures.
Brazil / Anvisa · BRA · Oct 29, 2018
Key facts
| Title | Alert 2710 (Technovigilance) - Medtronic Comercial Ltda - Stealthstation S7 System - Stealthstation i7 Surgical Navigation System - Possibility of inaccuracy during biopsy procedures. |
|---|---|
| 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: N/A 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 | N04144365, N04108688, 10339190361, N04241189, N06245894, N04005354, N04128564, N06040428, N07330750, N06245893, N04131056, N06248803 and 8 more |
| 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