da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical… — Class II medical device recall Z-2630-2017
Terminated recall by Intuitive Surgical, Inc., reported 2017-07-05, distributed nationwide. da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqu
| Recall number | Z-2630-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2017-06-01 |
| Classified | 2017-06-26 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2017-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR, IE, JP, TW |
| Quantity | 10 units |
| Serial numbers | SK0822, SK1001, SK1040, SK1082, SK1146, SK1154, SK1170, SK1176, SK1180, SK1190 |
Product
da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (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 in the pelvic, abdominal, and thoracic cavities.
Reason for recall
da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
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-2630-2017. 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.