Intuitive Surgical, Inc. recalls da Vinci SP surgical system

Recall date

April 1, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2260-2020

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

da Vinci SP surgical system