Medical device recalls Moderate risk

Intuitive Surgical, Inc. recalls da Vinci Xi Surgical System

Recall date
November 21, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1960-2020
FDA classification
Class II
Brand / firm
Intuitive Surgical, Inc.
Sold / distributed
U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan.

Why it was recalled

Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.

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 Xi Surgical System

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