Class II — Intuitive Surgical Inc
| Recalling firm | Intuitive Surgical, Inc. |
|---|---|
| Registered facility | View this company's 41 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | da Vinci X Surgical System, IS4200 - 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 … |
| Quantity | 270 USMs on a combination of 100 unique systems (4 USM per system) |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, District of Columbia, FL, GA, IL, IN, IA, KS. MA, MI, MS, NB, NY, OH, PA, TN, TX, VA, WA and WI and the countries of Australia, Belgium, Brazil, France, Germany, India, Italy, Japan, South Korea, Spain, Sweden, and the United Kingdom. |
| Initiated | 2019-04-11 |
| Classified | 2020-05-05 |
| Terminated | 2024-04-08 |
| Recall number | Z-1897-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Intuitive Surgical Inc (Z-1897-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83482/
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