da Vinci¿ Xi" Surgical System — Class II medical device recall Z-0315-2017
Terminated recall by Intuitive Surgical, Inc., reported 2016-11-02, distributed in PR. Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpec
| Recall number | Z-0315-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2016-10-05 |
| Classified | 2016-10-26 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2017-05-01 |
| Distributed | PR |
| Countries outside the US | AT, AU, BE, CH, CO, CY, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, KR, NL, NO, PT, QA, RO, SE, TR, TW |
| Quantity | 677 devices |
| Reason classes | software |
| Model numbers | IS4000 |
Product
da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
Reason for recall
Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances
Machine access
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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.