Company: Intuitive Surgical, Inc.
Date of Enforcement Report: 6/10/2020
Class II
PRODUCT
da Vinci SP surgical system
Recall Number: Z-2260-2020
REASON
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.
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc. on 4/1/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
17
DISTRIBUTION
US Nationwide and International