0 deg — Class II medical device recall Z-0652-2016
Terminated recall by Intuitive Surgical, Inc., reported 2016-01-20, distributed nationwide. This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes
| Recall number | Z-0652-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2015-11-23 |
| Classified | 2016-01-14 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-04-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CY, CZ, DE, DK, ES, FR, GB, HK, IL, IN, IT, JP, KR, NL, NO, QA, RO, SA, SE, SG, TR, TW, VE |
| Quantity | 2,624 all |
| Lot numbers | 8MM |
| Model numbers | 470026-34, 470026-40, 470026-41 |
Product
0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.
Reason for recall
This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments. It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources.
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-0652-2016. 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.