da Vinci Xi Surgical System P4 software — Class II medical device recall Z-2734-2015
Terminated recall by Intuitive Surgical, Inc., reported 2015-09-09, distributed nationwide. Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version so
| Recall number | Z-2734-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2015-08-17 |
| Classified | 2015-09-03 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2016-02-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT, NO |
| Quantity | 198 affected |
| Reason classes | software |
| Serial numbers | SK0036, SK0039, SK0046, SK0047, SK0048, SK0049, SK0051, SK0054, SK0057, SK0058, SK0059, SK0061, SK0062, SK0066, SK0067, SK0069, SK0070, SK0071, SK0072, SK0074, SK0076, SK0077, SK0079, SK0081, SK0087 and 171 more |
| Model numbers | IS4000 |
Product
da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : 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 thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.
Reason for recall
Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.
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-2734-2015. 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.