da Vinci Si — Class II medical device recall Z-1191-2016
Terminated recall by Intuitive Surgical, Inc., reported 2016-03-30.
| Recall number | Z-1191-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2016-02-16 |
| Classified | 2016-03-18 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2016-09-21 |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CL, CN, CZ, DE, DK, FI, FR, GB, HK, IL, IN, IT, JP, KR, MY, NL, PH, PT, QA, RO, SA, SE, TR, TW, VE |
| Serial numbers | RSH0020, SD0003, SD0004, SD0005, SH0034, SH0074, SH0164, SH0272, SH0280, SH0329, SH0416, SH0473, SH0607, SH0741, SH0881, SH0934, SH0938, SH0948, SH1011, SH1104, SH1228, SH1350, SH1356, SH1378, SH1380 and 322 more |
| Model numbers | 187505-04, IS3000/IS4000SCC, M187505-04 |
Product
da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.
Reason for recall
Not stated by FDA.
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-1191-2016. 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.