International safety notice
System for endoscopic surgery
Brazil / Anvisa · BRA · Apr 6, 2016
Key facts
| Title | System for endoscopic surgery |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Product name: DA VINCI ROBOTIC SURGICAL SYSTEM - INTUITIVE SURGICAL /// ANVISA registration number: 10302860146/// Risk class: III/// Affected model(s): da Vinci Si Surgical System and da Vinci Si Surgical System Vinci Xi, however in Brazil only the da Vinci Si model is sold.///Serial number(s) affected: All serial numbers manufactured until November 2015, however in Brazil we only have the following serial numbers series: SH2344;SH2341;SH2362; |
| Manufacturer | DETENTOR DO REGISTRO NO BRASIL H STRATTNER CIA LTDA CNPJ 33250713000162 ENDEREÇO RUA RICARDO MACHADO 904 VASCO DA GAMA MUNICÍPIO RIO DE JANEIROUF RJ TELEFONE DE CONTATO 21 21211300 FABRICANTE INTUITIVE SURGICAL INC ENDEREÇO 950 KIFER ROAD SUNNYVALLE CA 940865206 PAÍS EUA |
| Models | SH2362, 10302860146, SH2339, SH2361, SH2338, SH2312, SH2341, SH2344, SH2360 |
| Date | Apr 6, 2016 |
| 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