Back to search
FDAFDA · Food and drugs·Recall number Z-0315-2017

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.

Published November 2, 2016 · Recall initiated: October 5, 2016

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Telephone

Recall details

Manufacturer
Intuitive Surgical, Inc.
Distributor
Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Qatar, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Lot
All systems manufactured with or upgraded to P5 software.
Risk classification
Class II
Area (FDA)
device
Country
United States

Sell products like this?

Recalert watches your whole catalog for recalls like this one, automatically.

Start free — no card