Recall – Robotic surgery system software triggers vibration under certain conditions

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

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