FDA Device recall Z-0315-2017
da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software
- FDA Device
- Class II
- terminated
- Published 2016-11-02
On 2016-11-02 the FDA classified a Class II recall of da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software by Intuitive Surgical, citing 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 certa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0315-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-05 |
| Published | 2016-11-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Intuitive Surgical |
| Distribution | PR |
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
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
Identifiers
| code_info | All systems manufactured with or upgraded to P5 software. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0315-2017%22
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