da Vinci Xi Surgical System — Class II medical device recall Z-1302-2015
Terminated recall by Intuitive Surgical, Inc., reported 2015-04-01, distributed nationwide. Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positio
| Recall number | Z-1302-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2015-03-03 |
| Classified | 2015-03-20 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2015-09-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CH, CN, DE, ES, FR, GB, IL, IN, IT, KR, NO, SE, TR |
| Quantity | 167 da |
| Serial numbers | 1311140008, 1311140014, 1311140054, 1311140081, 1311140088, 1311140098, 1311140099, 1311140115, 1311140148, 1311140152, 1311140188, 1311140189, 1311140195, 1311140220, 1311140225, 1311140237, 1311140238, 1311140273, 1311140306, 1311140324, 1311140325, 1311140332, 1311140336, 1311140353, 1311140355 and 19 more |
| Model numbers | IS4000 |
Product
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic 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 labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.
Reason for recall
Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.
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-1302-2015. 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.