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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