Intuitive Surgical, Inc. recalls Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X

Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.

Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X 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

On 04/02/2026, the firm sent via 2-day mailing service an "Urgent Medical Device Correction" letter to customers informing them that Intuitive identified that the screws on the cannula mount of the USM from a specific population are susceptible to breaking over time. When the cannula mount experiences a breakage of all six screws, the mount can separate from the rest of the USM. Breakage of any fewer than six screws will not result in cannula mount separation, or impact to clinical performance. How to recognize issue/failure: Screw breakage or cannula mount loosening may be observable as visible or tactile separation of the cannula mount from the body of the USM. Prior to a procedure, closely inspect the joint between the cannula mount and insertion axis that is joined by the screws in Figure 1 in the Urgent Medical Device Correction Letter. Manipulate the cannula mount joint by hand to ensure there is no movement or looseness. If looseness or separation is observed, discontinue use of the USM and contact representative to schedule a site visit. If all six screws were to break intra-operatively, the user may also observe imprecise or unintended instrument tip motion. If observed imprecise or unintended instrument tip motion, inspect the cannula mount for looseness or separation and if present, discontinue use of the USM and contact representative to schedule a site visit. Customers are instructed to: 1. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred. 2. Retain a copy of letter, place with your affected system, and keep a copy of the acknowledgement form for your files. For Questions: North/South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com. Europe/Middle East/Asia/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

• FDA enforcement recordOfficial FDA database entry for Z-2046-2026
• FDA 510(k) clearance · K131861The device's official FDA premarket clearance record
• FDA 510(k) clearance · K171294The device's official FDA premarket clearance record
• FDA device classification · NAYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1500The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Intuitive Surgical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.