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Intuitive Surgical, Inc. recalls da Vinci SP surgical system
Recalled June 10, 2020 · FDA recall Z-2260-2020 · Intuitive Surgical
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. · FDA Class II
Units
17
Sold at
U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea
Description
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.
Product
da Vinci SP surgical system
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →