IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System — Class II medical device recall Z-1109-2013
Terminated recall by Intuitive Surgical, Inc., reported 2013-04-24, distributed nationwide. Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding st
| Recall number | Z-1109-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2013-03-15 |
| Classified | 2013-04-13 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2014-09-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, DE, DK, FI, FR, GB, IE, KR, NL, NO, SE |
| Quantity | 1,642 customers |
| Reason classes | sterility |
| Model numbers | 550516-05, IS2000 |
Product
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
Reason for recall
Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
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-1109-2013. 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.