FDA-Device2020-05-20Class II
da Vinci Xi Surgical System
Intuitive Surgical, Inc.
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.
Sold states
U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan.
Affected count
74 USMs containing affected rotors.
Manufactured in
1266 Kifer Rd Bldg 101, N/A, Sunnyvale, CA, United States
Products
da Vinci Xi Surgical System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1960-2020Don't want to check this manually?
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