ASSEMBLY — Class II medical device recall Z-2731-2014
Terminated recall by Intuitive Surgical, Inc., reported 2014-10-08, distributed nationwide. Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci
| Recall number | Z-2731-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2014-09-11 |
| Classified | 2014-09-29 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2014-10-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CN, DE, GB, HK, IL, IN, IT |
| Quantity | 75 devices |
| Serial numbers | 349166, 351052, 351749, 351845, 351849, 351852, 351853, 351929, 353410, 353632, 353668, 354233, 354234, 354389, 354552, 354714, 354943, 355206, 355623, 355824, 355996, 356258, 356530, 356532, 356533 and 50 more |
| Model numbers | 380652, IS4000 |
Product
ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: 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. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Reason for recall
Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart.
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.