Intuitive Surgical da Vinci Xi System: Persistent Fault Error Risk
Intuitive Surgical recalls da Vinci Xi surgical systems with a manufacturing variation causing persistent error 23087 that may lead to loss of arm functionality during surgery. Affected units include specific model and UDI numbers.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Intuitive Surgical is recalling da Vinci Xi surgical systems that have a manufacturing issue causing a persistent error that could lead to loss of arm function during surgery. This affects specific models and serial numbers, and users should contact the company for details. Read more at govinfonow.com/recall/69440-intuitive-surgical-da-vinci-xi-system-persistent-fault-error-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69440-intuitive-surgical-da-vinci-xi-system-persistent-fault-error-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1960-2020
Cite this page
“Intuitive Surgical da Vinci Xi System: Persistent Fault Error Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69440-intuitive-surgical-da-vinci-xi-system-persistent-fault-error-risk. Based on FDA recall #Z-1960-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1960-2020%22&limit=1).
Why it’s dangerous
A manufacturing variation in the robotic arm can cause a persistent error (23087) that may lead to loss of arm functionality during surgery. This could affect the precision of the robotic system while operating.
Who’s affected
Surgical teams using the da Vinci Xi system with the specific model and UDI numbers listed in the recall notice. Patients undergoing surgery with this system are at risk if the error occurs.
How to tell if you have this one
Check for the model number IS4000 and UDI number 00886874114216 on the device. Affected units are identified through the specific product listing and serial numbers provided in the recall notice.
- Brand
Intuitive Surgical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1960-2020 | 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. | 74 USMs containing affected rotors. |
| Z-1961-2020 | da Vinci X Surgical System; Model: IS4200 UDI: 00886874114216 Device Listing: D295931 | 74 USMs containing affected rotors |
What to do — step by step
Contact Manufacturer
Reach out to Intuitive Surgical for specific product details and instructions on how to address the issue.
Where it went and when
Where it was distributed
Distributed in 13 states, and outside the U.S.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Delaware, Florida, Illinois, Kentucky, Maryland, Massachusetts, Michigan, New Jersey, New York, Ohio, Texas, Virginia.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1960-2020 (November 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1960-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.