da Vinci X Surgical System — Class II medical device recall Z-1961-2020
Terminated recall by Intuitive Surgical, Inc., reported 2020-05-20, distributed in CA, DE, FL, IL, KY, MA, MD, MI…. Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 230
| Recall number | Z-1961-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2018-11-21 |
| Classified | 2020-05-11 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2022-05-31 |
| Distributed | CA, DE, FL, IL, KY, MA, MD, MI, NJ, NY, OH, TX, VA |
| Countries outside the US | AU, DE, FR, JP |
| Quantity | 74 usms |
| UPC / GTIN / UDI-DI | 00886874114216 |
| Model numbers | IS4200 |
Product
da Vinci X Surgical System
Reason for recall
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1961-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.