International safety notice
Alert 2644 (Technosurveillance) - H. Strattner e Cia Ltda - da Vinci Intuitive Surgical Robotic Surgical System - Possibility of not activating the Surgeon Console and/or Patient Cart in the event of an electrical failure.
Brazil / Anvisa · BRA · Aug 13, 2018
Key facts
| Title | Alert 2644 (Technosurveillance) - H. Strattner e Cia Ltda - da Vinci Intuitive Surgical Robotic Surgical System - Possibility of not activating the Surgeon Console and/or Patient Cart in the event of an electrical failure. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: da Vinci Robotic Surgical System - Intuitive Surgical Technical Name: System for Endoscopic Surgery ANVISA registration number: 10302860146 Risk Class: III Affected model: IS3000 Affected serial numbers: SH2406, SH2407 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO H STRATTNER E CIA LTDA CNPJ 33250713000162 RUA RICARDO MACHADO 904 VASCO DA GAMA RIO DE JANEIRO RJ TEL 21 21211300 EMAIL QUALIDADESTRATTNERCOMBR FABRICANTE DO PRODUTO INTUITIVE SURGICAL INC 1266 KIEFER ROAD SUNNYVALE CALIFÓRNIA 94086 ESTADOS UNIDOS DA AMÉRICA |
| Models | SH2407, IS3000, 10302860146, SH2406 |
| Date | Aug 13, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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