IS3000 Vision Side Cart — Class II medical device recall Z-0940-2015
Terminated recall by Intuitive Surgical, Inc., reported 2015-01-14, distributed nationwide. Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Car
| Recall number | Z-0940-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2014-12-05 |
| Classified | 2015-01-07 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2015-03-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, DE, ES, FR, GB, IL, IN, IT, KR, NO, RO, SE, TR |
| Quantity | 202 |
| Serial numbers | SH0018, SH0019, SH0021, SH0024, SH0025, SH0026, SH0028, SH0029, SH0030, SH0031, SH0032, SH0033, SH0034, SH0035, SH0036, SH0037, SH0038, SH0039, SH0040, SH0041, SH0042, SH0044, SH0045, SH0046, SH0047 and 177 more |
| Model numbers | IS3000, VS3000 |
Product
IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and noncardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
Reason for recall
Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening.
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-0940-2015. 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.