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Intuitive Surgical, Inc. recalls da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon
Recalled July 5, 2017 · FDA recall Z-2630-2017 · Intuitive Surgical
Hazard
da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms. · FDA Class II
Units
10 units
Sold at
Worldwide Distribution - US Nationwide in the states of TX, NY,FL, IL, OH, and countries of France, Ireland, Japan, and Taiwan
Description
da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
Product
da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (arms) which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures in the pelvic, abdominal, and thoracic cavities.
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →