Use caution Medical device recall · FDA · Published September 20, 2022

Intuitive Surgical da Vinci X and Xi Systems Recall: Risk of Unintended Energy Delivery

Intuitive Surgical recalls da Vinci X and Xi surgical systems with software version P10 due to risk of unintended energy delivery causing injury if specific conditions are met.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0133-2023Medical device Intuitive Surgical ›

Use caution until it’s fixed

Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery

Take action

Contact the company

Recalling firmIntuitive Surgical, Inc.1266 Kifer Rd Bldg 101 · Sunnyvale, CA 94086-5304

✎ GovInfoNow plain-language explainer

Intuitive Surgical is recalling da Vinci X (IS4200) and Xi (IS4000) surgical systems because a software issue can cause unintended energy delivery from instruments during surgery. This could lead to injury if certain conditions are met, such as specific instrument connections and pedal actions. Read more at govinfonow.com/recall/60034-intuitive-surgical-da-vinci-x-and-xi-systems-recall-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/60034-intuitive-surgical-da-vinci-x-and-xi-systems-recall-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0133-2023

Cite this page

“Intuitive Surgical da Vinci X and Xi Systems Recall: Risk of Unintended Energy Delivery.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60034-intuitive-surgical-da-vinci-x-and-xi-systems-recall-risk. Based on FDA recall #Z-0133-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0133-2023%22&limit=1).

The FDA announced on Sept. 20, 2022, that Intuitive Surgical, Inc. is recalling da Vinci X (IS4200) and Xi (IS4000) surgical systems due to the hazard of inadvertent energy delivery. The recall involves 162 units distributed across multiple U.S. states.

How to tell if you have it

Brand: Intuitive Surgical
Product: da Vinci X (IS4200) and Xi (IS4000) systems
Components: Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
Software version: P10 (OS4 v10.0.0/A70_P10_B738)
Model/UDI-DI codes: 610092-738, 380652-55, 00886874110720, 380677-28, 00886874110744, 381121-45, 00886874110898, 380620-47, 00886874115404, 380721-15, 00886874115343, 380723-16, 00886874115374
Quantity: 162 units

The hazard

The systems pose a hazard of inadvertent energy delivery from surgical system instruments. This risk arises if force bipolar and bipolar instruments are installed on the system, or if specific pedal interactions occur with the Force Triad generator.

Context

GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since June 1, 2017. Recent brand recalls include a Da Vinci 5 dV5 Tower NIR Handheld Camera recall on April 24, 2026, and an E-Brake Pin Risk recall on April 22, 2026. Other recent recalls of similar products include a Vortex Surgical TID Pharos Illuminated Depressor recall (Dec. 16, 2025), an Olympus HX-400U-30 Ligating Device recall (Oct. 30, 2025), and a GE Healthcare Carestation Anesthesia System Power Board recall (Nov. 14, 2025).

How to tell if you have this one

Check for da Vinci X (IS4200) or Xi (IS4000) systems with software version P10 (OS4 v10.0.0/A70_P10_B738). The model numbers include 610092-738, 380652-55, and others listed in the recall notice.

Brand
Intuitive Surgical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your system; affected units have version P10 (OS4 v10.0.0/A70_P10_B738).
Contact Manufacturer
Reach out to Intuitive Surgical for guidance on next steps and potential remedies.

Where it went and when

Where it was distributed

Distributed in 27 states.

FDA distribution: “US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD, TX, IA, MA, NE, AZ, WA, CO, AL, SC” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, Nevada, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin.

Recall timeline

FDA published this recall 43 days after the firm started it.

Sep 20, 2022Firm started the recall
Oct 25, 2022FDA classified it Class II
Nov 2, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/60034-intuitive-surgical-da-vinci-x-and-xi-systems-recall-risk">Intuitive Surgical da Vinci X and Xi Systems Recall: Risk of Unintended Energy Delivery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0133-2023 (September 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0133-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.