Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200

FDA device recall Z-2046-2026 · posted 2026-05-01 · Open, Classified

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

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

Action taken

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

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

NAY

Quantity affected

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,

Date initiated

2026-04-02

Date posted

2026-05-01

Location

Sunnyvale, CA

Related 510(k) clearances