Intuitive Surgical da Vinci Xi Surgical System: Under-torqued brake screws risk patient
Intuitive Surgical recalls da Vinci Xi Surgical System (IS4000) units with potentially under-torqued brake screws in patient side carts. This could cause system arm movement during surgery, risking patient injury. Affected units have specific serial numbers listed in the recall.
Use caution until it’s fixed
da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
Contact the company
What happened, in plain English
Intuitive Surgical is recalling da Vinci Xi Surgical System (IS4000) units that may have under-torqued brake screws in the patient side carts. This could cause unintended movement of the surgical arms during procedures, potentially leading to patient injury. Affected units have specific serial numbers listed in the recall. Read more at govinfonow.com/recall/73983-intuitive-surgical-da-vinci-xi-surgical-system-under-torqued-brake.
Source Summary by GovInfoNow · govinfonow.com/recall/73983-intuitive-surgical-da-vinci-xi-surgical-system-under-torqued-brake · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2630-2017
Cite this page
“Intuitive Surgical da Vinci Xi Surgical System: Under-torqued brake screws risk patient.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73983-intuitive-surgical-da-vinci-xi-surgical-system-under-torqued-brake. Based on FDA recall #Z-2630-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2630-2017%22&limit=1).
Why it’s dangerous
The patient side carts (PSC) in the da Vinci Xi Surgical System may have brake screws that are not properly tightened. This could allow the surgical arms to move unexpectedly during surgery, potentially causing injury to the patient.
Who’s affected
Surgical teams using the da Vinci Xi Surgical System (IS4000) are affected. Patients undergoing surgery with this system may be at risk if the patient side carts have under-torqued brake screws.
How to tell if you have this one
Check if your da Vinci Xi Surgical System (IS4000) has the serial numbers SK0822, SK1154, SK1001, SK1170, SK1040, SK1176, SK1082, SK1180, SK1146, or SK1190. These specific units were shipped with potentially under-torqued brake screws.
- Brand
Intuitive Surgical- Category
Medical device
What to do — step by step
Check Serial Numbers
Verify if your da Vinci Xi Surgical System (IS4000) has one of the listed serial numbers: SK0822, SK1154, SK1001, SK1170, SK1040, SK1176, SK1082, SK1180, SK1146, or SK1190.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 5 states.
FDA distribution: “Worldwide Distribution - US Nationwide in the states of TX, NY,FL, IL, OH, and countries of France, Ireland, Japan, and Taiwan” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Illinois, New York, Ohio, Texas.
Recall timeline
FDA terminated this recall 4 months 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-2630-2017 (June 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2630-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.