FDA-Device2020-06-10Class II
da Vinci SP surgical system
Intuitive Surgical, Inc.
Hazard
Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.
Sold states
U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea
Affected count
17
Manufactured in
1266 Kifer Rd Bldg 101, N/A, Sunnyvale, CA, United States
Products
da Vinci SP surgical system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2260-2020Don't want to check this manually?
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