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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Intuitive Surgical da Vinci Xi, X, and 5 surgical systems recalled for potential instrument arm failure

Intuitive Surgical
OTHERNationwide distribution

Check da Vinci surgical system instrument arms

A software error allowed robotic instrument arms with bent or misaligned parts to remain in use during surgery. These parts can wear out and potentially fail during a procedure. Intuitive Surgical identified specific serial numbers of affected systems.

  • If your facility operates a da Vinci Xi, X, or 5 system, check if your system serial number matches the FDA recall list
  • Contact Intuitive Surgical immediately if your system is affected
  • Do not use affected systems until you receive further instructions from the manufacturer
  • Follow any software updates or service instructions provided by Intuitive Surgical
Hazard

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

Sold states
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
Affected count
219
Manufactured in
1266 Kifer Rd, N/A, Sunnyvale, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1232-2026

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