Recall Z-1232-2026— Intuitive Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2025-11-07. It names 3 FDA 510(k) clearances: K232610, K171294, K131861. Product: 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, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument. 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.
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-11-07
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K232610 — da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
- K171294 — da Vinci X Surgical System
- K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.