Intuitive Surgical Recalls da Vinci X, Xi, and 5 Surgical Systems Due to Software Error

What Happened

Intuitive Surgical, Inc. has initiated a voluntary recall of several da Vinci surgical system models due to a software implementation error. This error allowed Universal Surgical Manipulator (USM) arms that failed a critical diagnostic test to remain in clinical use. The diagnostic test is intended to detect bent or misaligned insertion axis ball screws, which are precursors to potential fatigue failure or fraction of the component.

Which Products Are Affected

The recall affects 219 units across the following product lines and models:

• Brand Names: da Vinci X, da Vinci Xi, and da Vinci 5 Surgical Systems
• Model/Catalog Numbers: IS4000, IS4200, and IS5000
• Affected Component: USM sub-component part number 380647-xx
• UDIs: 00886874114216, 00886574119747
• Recall Number: Z-1232-2026

Geographic Distribution:

• United States: AL, AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MD, MI, MN, MS, MO, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI.
• International: Austria, Brazil, China, France, Germany, Greece, India, Italy, Japan, Lebanon, Netherlands, South Korea, Spain, Switzerland, Taiwan, and United Kingdom.

What You Should Do

Intuitive Surgical, Inc. notified affected customers via an initial firm notification letter sent on November 7, 2025. Healthcare facilities and surgical centers using the da Vinci X, Xi, or 5 systems should review their inventory for the affected serial numbers listed in the firm’s notification. If a system is identified as part of the recall, users should follow the specific guidance provided by the manufacturer regarding the inspection or replacement of the USM arms.

Why This Matters

This recall is critical because the failure to identify bent or misaligned ball screws could lead to the mechanical failure of a robotic arm during a surgical procedure. Such a failure poses a risk to patient safety and the successful completion of surgical tasks like cutting or suturing.

Source

Information provided by the FDA.