Intuitive Surgical, Inc.: System, Surgical, Computer Controlled Instrument
Intuitive Surgical is recalling the robotic arms (manipulators) used in da Vinci X and da Vinci Xi surgical systems because screws in the arm assemblies may break. The affected systems are distributed worldwide, including across all U.S. states and numerous countries. This is a Class II recall, meaning the problem could cause serious harm but is not immediately life-threatening.
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- 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...
- Reason
- Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-02
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Argentina,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/fefa27af-aa19-4e7a-abeb-d1a984bf6be9