Devices

Device Recall daVinci

  • Modèle / numéro de série
    Model number 552002-01
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution Only
  • Description du dispositif
    User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. || Product Usage: || The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.
  • Manufacturer
    Intuitive Surgical, Inc.
  • 1 Event

Fabricant

Intuitive Surgical, Inc.
  • Adresse du fabricant
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Société-mère du fabricant (2017)
    Intuitive Surgical Inc
  • Source
    USFDA

3 dispositifs médicaux avec un nom similaire

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Device Recall daVinci Surgical System Model IS1200, A4.3 SW level
  • Modèle / numéro de série
    Systems manufactured or upgraded to Model IS1200 hardware/software level in this time frame: 2/17/2000 - 3/27/2007
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Romania, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.
  • Description du dispositif
    Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Manufactured by Intuitive Surgical, Inc, Sunnyvale, CA 94086
  • Manufacturer
    Intuitive Surgical, Inc.
Device Recall daVinci S Surgical System IS2000
  • Modèle / numéro de série
    Model number IS2000, part number 351040-04. System numbers SG002, SG004, SG010 , SG032, SG060, SG061, SG064, SG065, SG066, SG067, SG068, SG069, SG070, SG071, SG072, SG073, SG074, SG075, SG076, SG077, SG078, SG079, SG080, SG081, SG082, SG083, SG084, SG086, SG090, SG116, SG117, SG118, SG120, SG121, SG126, SG174, SG175, SG184
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, France, China, Japan, Mexico, Spain, Italy, Belgium and Singapore.
  • Description du dispositif
    daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system.
  • Manufacturer
    Intuitive Surgical, Inc.
Device Recall daVinci S Surgical System IS2000
  • Modèle / numéro de série
    Model Number: IS 2000, Software Revision Numbers: A5.0 P5 and A5.1 P1. System Numbers: all starting with "SG"-- 043, 156, 088, 128, 065, 104, 106, 132, 019, 051, 058, 083, 092, 096, 165, 170, 098, 105, 157, 050, 112, 125, 138, 149, 034, 061, 121, 030, 044, 052, 054, 068, 069, 123, 147, 151, 013, 113, 152, 014, 049, 077, 134, 136, 066, 085, 091, 129, 087, 139, 140, 042, 047, 031, 089, 017, 021, 022, 115, 116, 137, 155, 168, 169, 041, 095, 119, 163, 164, 114, 057, 060, 101, 117, 122, 029, 020, 028, 056, 093, 094, 141, 103, 072, 084, 011, 024, 036, 053, 059, 144, 145, 146, 026, 074, 154, 018, 027, 055, 070, 109, 110, 111, 118, 120, 135, 099, 232, 033, 082, 148, 012, 015, 039, 067, 102, 124, 161, 166, 037, 097, 040, 064, 090, 127, 133, 025, 062, 143, 160, 038, 153, 035, 071, 073, 107, 158, 167, 086, 131, 063, 080, 078, 159, 076, 045, 081, 108, 150, 046, 075, 130, 004, 005, 006, 007, 010, 048, and 126
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, Belgium, China, France, India, Italy, Japan, Korea, Spain, Sweden, Switzerland, UK and Mexico.
  • Description du dispositif
    Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Intuitive Surgical, Sunnyvale, CA 94086.
  • Manufacturer
    Intuitive Surgical, Inc.