Devices

da Vinci Xi Surgical System

Manufacturer

Transmedic Pte Ltd
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HSAHSA

29 devices with a similar name

Learn more about the data here

EndoWrist stapler system (for da Vinci Xi surgical system)
da Vinci Xi Surgical System
da vinci xi surgical system
da vinci si hd surgical system da vinci s surgical system da vinci si surgical system da vinci xi...
Device Recall da Vinci Xi Surgical System
  • Model / Serial
    Material number: 3680662-20: Serial numbers: 1311140273, 1311140370, 1311140385, 1311140148, 1311140099, 1311140152, 1311140081, 1311140473, 1311140561, 1311140409.  Material number: 380662-21: Serial numbers: 1311140225, 1311140437, 1311140476, 1311140336,  1311140472, 1311140438, 1311140353, 1311140195, 1311140545, 1311140098 1311140189, 1311140465, 1311140394, 1311140366, 1311140008, 1311140115 1311140014, 1311140371, 1311140238, 1311140306, 1311140332, 1311140404 1311140054, 1311140188, 1311140324, 1311140453, 1311140408, 1311140237 1311140220, 1311140372, 1311140325, 1311140088, 1311140535, 1311140355.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, France, Germany, India, Israel, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Product Description
    da Vinci Xi Surgical System, IS4000; || Assy, Distal SUJ, Inner, IS4000 || Material number: 380662-20 and 380662-21. || The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, || endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical || procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.
  • Manufacturer
    Intuitive Surgical, Inc.
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