Is da Vinci Xi Surgical System 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. Status: Voluntary: Firm initiated Initial Firm Notification: Letter Distribution: U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan.

Medium RiskFDA Device

Intuitive Surgical, Inc.: 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.

Agency Publication Date: May 11, 2020

Affected Products

Product: da Vinci Xi Surgical System

Model: IS4000 UDI: 00886874114216 Device Listing: D215864 For System Name and USM Serial Numbers, refer to: ISIFA2018-15-C 806.10 Report_Affected Products List - Copy" files in Associated Documents.

Product: da Vinci X Surgical System

Model: IS4200 UDI: 00886874114216 Device Listing: D295931

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84023

Status: Resolved

Manufacturer: Intuitive Surgical, Inc.

Manufactured In: United States

Units Affected: 2 products (74 USMs containing affected rotors.; 74 USMs containing affected rotors)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.