Intuitive Surgical recalls Da Vinci X, Xi, and 5 surgical systems due to a software error that allows malfunctioning instrument arms to remain in use, potentially leading to ball screw fatigue failure.
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
Intuitive Surgical is recalling Da Vinci X, Xi, and 5 surgical systems because a software error can cause instrument arms to fail a critical diagnostic test, which might lead to ball screw fatigue failure. This could pose a risk during surgery if the arms become misaligned.
The software error allows instrument arms to bypass a diagnostic test that checks for bent or misaligned ball screws. If ball screws become fatigued, they could fail during surgery, potentially causing injury to the patient.
Surgical teams using Da Vinci X, Xi, or 5 systems with the specific USM serial numbers listed in the recall notice. Surgeons and surgical staff are most at risk if the system is used without the software fix.
Check if your Da Vinci system has USM serial numbers listed in the provided recall notice (e.g., 402229 SK0835 for Da Vinci Xi). The affected models are Da Vinci X, Xi, and 5 surgical systems with specific serial numbers.
Review the USM serial numbers listed in the recall notice to confirm if your system is affected.
Reach out to Intuitive Surgical for guidance on the next steps if your system is affected.
The recall is due to a software error that allows instrument arms to fail a critical diagnostic test, which could lead to ball screw fatigue failure during surgery.
Check if your Da Vinci X, Xi, or 5 system has USM serial numbers listed in the provided recall notice.
Contact Intuitive Surgical for guidance on the next steps if your system is affected.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1232-2026 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1232-2026 from Intuitive Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
