Intuitive Surgical, Inc. recalls da Vinci SP surgical system
Recalled Product
da Vinci SP surgical system
Hazard / Issue
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.
Issued by
FDA
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