da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console… — Class II medical device recall Z-0088-2014
Terminated recall by Intuitive Surgical, Inc., reported 2013-11-06, distributed nationwide. Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose
| Recall number | Z-0088-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2011-10-17 |
| Classified | 2013-10-28 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2013-10-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CL, CN, DE, DK, EG, ES, FI, FR, GB, GR, ID, IE, IL, IN, IT, KR, KW, MX, NL, NO, PH, PL, PT, QA, RO, SA, SE, SG, SK, TH, TR, TW |
| Quantity | 1,090 consoles |
| Model numbers | 380610-04 |
Product
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
Reason for recall
Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
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-0088-2014. 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.