Intuitive Surgical da Vinci Xi and X Systems Recall: Loose USM Carriage Risk
Intuitive Surgical recalls da Vinci Xi (IS4000) and X (IS4200) surgical systems with loose Universal Surgical Manipulator carriage due to manufacturing defects. Affected units have specific serial numbers.
Use caution until it’s fixed
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
Contact the company
What happened, in plain English
Intuitive Surgical is recalling da Vinci Xi (IS4000) and X (IS4200) surgical systems because the Universal Surgical Manipulator carriage may become loose due to a manufacturing defect. This could potentially cause the system to malfunction during surgery. Read more at govinfonow.com/recall/58911-intuitive-surgical-da-vinci-xi-and-x-systems-recall-loose.
Source Summary by GovInfoNow · govinfonow.com/recall/58911-intuitive-surgical-da-vinci-xi-and-x-systems-recall-loose · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1293-2023
Cite this page
“Intuitive Surgical da Vinci Xi and X Systems Recall: Loose USM Carriage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58911-intuitive-surgical-da-vinci-xi-and-x-systems-recall-loose. Based on FDA recall #Z-1293-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1293-2023%22&limit=1).
Why it’s dangerous
The Universal Surgical Manipulator (USM) instrument carriage may become loose because the linear rail component wasn't manufactured to specifications. This could cause the system to malfunction during surgery, potentially affecting the precision of surgical instruments.
Who’s affected
Surgical teams using the da Vinci Xi (IS4000) or X (IS4200) systems with specific serial numbers listed in the recall. Surgeons and surgical staff are most at risk if the system malfunctions during procedures.
How to tell if you have this one
Check if your da Vinci Xi system has serial number IS4000 or da Vinci X system has serial number IS4200 from the list provided in the recall. The affected units have specific serial numbers listed in the document.
- Brand
Intuitive Surgical- Category
Medical device
What to do — step by step
Check System Serial Number
Identify your da Vinci Xi (IS4000) or X (IS4200) system's serial number to confirm if it's in the affected list.
Contact Manufacturer
Reach out to Intuitive Surgical directly for guidance on next steps if your system is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1293-2023 (February 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1293-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.