da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System… — Class II medical device recall Z-1293-2023
Ongoing recall by Intuitive Surgical, Inc., reported 2023-04-05, distributed in PR. Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail com
| Recall number | Z-1293-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2023-02-10 |
| Classified | 2023-03-28 |
| Reported by FDA | 2023-04-05 |
| Distributed | PR |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IS, IT, JP, KR, KW, KY, LB, LU, MT, MX, MY, NL, NO, NZ, PA, PH, PK, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TR, TW, UY, VE, VN, ZA |
| Quantity | 1,225 usms |
| UPC / GTIN / UDI-DI | 00886874114216 |
| Serial numbers | RSK8062, RSK8104, RSK8128, RSK8130, RSK8134, RSK8135, RSK8136, RSK8137, RSK8138, RSK8139, RSK8143, RSK8144, RSK8146, RSK8147, RSK8148, RSK8149, RSK8152, RSK8153, RSK8154, RSK8158, RSK8159, RSK8160, RSK8162, RSK8163, RSK8164 and 475 more |
| Model numbers | 380647, IS4000, IS4200 |
Product
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Reason for recall
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
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-1293-2023. 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.