Recall Z-1232-2026 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system,
| Date | Feb 2, 2026 (initiated Nov 7, 2025) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Process control |
| Action | 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, |
| Quantity | 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, Japan, Lebanon, Netherlands, South Korea, Spain, Switzerland, Taiwan and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc., Mar 28, 2014 |
| K171294 | da Vinci X Surgical System Intuitive Surgical, Inc., May 26, 2017 |
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation Intuitive Surgical, Inc., Mar 14, 2024 |