Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
da Vinci Xi Surgical System Recalled by Intuitive Surgical Inc Due to Failure of Universal Surgical Manipulators due to a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Intuitive Surgical Inc directly.
Affected Products
da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) 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. There are 4 USM per da Vinci Xi surgical system.
Quantity: 270 USM units on a combination of 100 unique systems
Why Was This Recalled?
Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Intuitive Surgical Inc
Intuitive Surgical Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report