Events

Recall of da Vinci Xi" Surgical System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intuitive Surgical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75473
  • Event Risk Class
    Class 2
  • Event Number
    Z-0315-2017
  • Event Initiated Date
    2016-10-05
  • Event Date Posted
    2016-10-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150460
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System,surgical,computer controlled instrument - Product Code NAY
  • 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.
  • Action
    Urgent Medical Device Correction letters were sent on October 12, 2016 by traceable method to all affected customers. Letters notify customers of the issue and provided instructions to prevent it from happening until ISI software can install new software upgrade in 1st Q 2017.

Device

da Vinci Xi" Surgical System
  • Model / Serial
    All systems manufactured with or upgraded to P5 software.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    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.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Manufacturer Address
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Manufacturer Parent Company (2017)
    Intuitive Surgical Inc
  • Source
    USFDA