Intuitive Surgical, Inc.: 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

Recall number

Z-2046-2026

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 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

Status

Open, Classified

Initiated

2026-04-02

Posted

2026-05-01

Terminated

not on file

Reason

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

Root cause

Nonconforming Material/Component

Action

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

Quantity

2781

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, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.

Lot, serial or model codes

Lot Code: UDI: 00886874114216 FDA Medical Device Listing Number: D531324 See attachment Affected Product List UDI: 00886874114216 FDA Medical Device Listing Number: D295931 See attachment Affected Product List

510(k) numbers

["K131861","K171294"]

PMA numbers

not on file

Product code

NAY

Firm FEI

3001675293

Firm city

Sunnyvale

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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