International safety notice
Alert 2648 (Technosurveillance) - Intuitive Surgical - System.
Brazil / Anvisa · BRA · Aug 15, 2018
Key facts
| Title | Alert 2648 (Technosurveillance) - Intuitive Surgical - System. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: da Vinci Robotic Surgical System - Intuitive Surgical / Endoscopic Instrument Control System da Vinci - Intuitive Surgical Technical Name: System for Endoscopic Surgery ANVISA registration number: 81166920001 Risk Class: III Affected model: 380610, 380614, 380649, 380677, 186610-02 Affected serial numbers: SK1602, SK1304, SK1226, SK1683, SK1554, SK1601, SK1734, SK1306, SK1423. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO INTUITIVE SURGICAL BRASIL IMPORTAÇÃO E COMÉRCIO DE EQUIPAMENTOS CIRÚRGICOS LTDA CNPJ 12506008000103 RUA PADRE MARINHO 49 SALAS 104 E 105 BAIRRO SANTA EFIGÊNIA BELO HORIZONTE MG TEL 55 11 964299876 EMAIL EMILENEMARTINSINTUSURGCOM FABRICANTE DO PRODUTO INTUITIVE SURGICAL INC 1266 KIFER ROAD SUNNYVALE CALIFÓRNIA 94086 ESTADOS UNIDOS DA AMÉRICA |
| Models | 380649, 380677, 380614, 380610, SK1683, SK1602, 186610-02, SK1306, SK1423, SK1226, SK1554, SK1304 and 3 more |
| Date | Aug 15, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
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