International safety notice

Alert 2904 (Technovigilance) Intuitive Surgical Brasil da Vinci X/Xi System Arm - Patient Cart Possibility that specific equipment arms present friction in specific orientations.

Brazil / Anvisa · BRA · Jun 11, 2019

Key facts

Title Alert 2904 (Technovigilance) Intuitive Surgical Brasil da Vinci X/Xi System Arm - Patient Cart Possibility that specific equipment arms present friction in specific orientations.
Regulator Brazil / Anvisa
Country BRA
Brand Commercial Name: da Vinci X/Xi - System Arm - Patient Cart Technical Name: System for Endoscopic Surgery ANVISA registration number: 81166920001 Risk Class: III Affected model: PS4000 Affected serial numbers: SK2297
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 EFIGENIA BELO HORIZONTE MG TEL 55 11 964199876 EMAIL EMILENEMARTINSINTUSURGCOM FABRICANTE DO PRODUTO INTUITIVE SURGICAL INC 1266 KIEFER ROAD SUNNYVALE CALIFORNIA 94086
Models PS4000, 81166920001, SK2297
Date Jun 11, 2019
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice

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