da Vinci Si Vision System Cart — Class II medical device recall Z-1687-2013
Terminated recall by Intuitive Surgical, Inc., reported 2013-07-17, distributed in AZ, CA, CO, FL, HI, MT, NY, TX…. Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testi
| Recall number | Z-1687-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2013-06-08 |
| Classified | 2013-07-11 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2014-01-22 |
| Distributed | AZ, CA, CO, FL, HI, MT, NY, TX, UT, WA |
| Countries outside the US | RU |
| Quantity | 30 total |
| Serial numbers | 323865, 323870, 323977, 324010, 324014, 324087, 324334, 324350, 324537, 324566, 324577, 324772, 324784, 324948, 325126, 325138, 325279, 325289, 325301, 325441, 325453, 325564, 325621, 325639, 325646 and 4 more |
| Model numbers | 380990-11, VS3000 |
Product
da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
Reason for recall
Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.
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-1687-2013. 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.