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Intuitive Surgical, Inc. recalls da Vinci X Surgical System
Recalled May 20, 2020 · FDA recall Z-1961-2020 · Intuitive Surgical
Hazard
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery. · FDA Class II
Units
74 USMs containing affected rotors
Sold at
U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan.
Description
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Product
da Vinci X Surgical System
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →