Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS
FDA device recall Z-1232-2026 · posted 2026-02-02 · Open, Classified
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- 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
- Action taken
- On 11/07/2025 and 11/13/2025, the firm emailed "Urgent Stop Use: Product Safety Notice" letters to customers informing them to stop use of specific da Vinci Surgical Systems. In 2022 Intuitive Surgical initiated a field action related to instrument arm ball screw failures. As a result, a field test was implemented to improve detection of affected ball screw. Intuitive has become aware that this test did not alert the service technicians of pass/fail results. Customer are instructed to immediately stop using affected da Vinci Systems. Intuitive will provide a formal follow-up communication, and our representative will contact you to schedule a site visit to perform the necessary corrections. Please distribute this communication to all relevant hospital personnel (e.g., surgeons, OR directors, risk managers, etc.) who use your affected da Vinci Surgical System. For Questions, contact Customer Service at: " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NAY
- Quantity affected
- 219
- Distribution
- U.S.: 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. O.U.S.: Austria, Brazil, China, France, Germany, Greece, India, Italy,
- Date initiated
- 2025-11-07
- Date posted
- 2026-02-02
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation (K232610) | Intuitive Surgical, Inc. | 2024-03-14 |
| da Vinci X Surgical System (K171294) | Intuitive Surgical, Inc. | 2017-05-26 |
| DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES (K131861) | Intuitive Surgical, Inc. | 2014-03-28 |