Events

Recall of Device Recall IS3000 USER MANUAL for Intuitive Surgical da Vinci Si 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
    64755
  • Event Risk Class
    Class 2
  • Event Number
    Z-1110-2013
  • Event Initiated Date
    2013-03-15
  • Event Date Posted
    2013-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116999
  • 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
    Revised instructions for users of the da vinci s, si and si-e systems with additional information regarding sterile adapter engagement and instrument installation.
  • Action
    Intuitive Surgical sent an "Urgent Medical Device Correction" letter dated April 1, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 800-876-1310 for questions regarding this letter.

Device

Device Recall IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System
  • Model / Serial
    Model number 550650-05 (P8)
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
  • Product Description
    IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. || Arm drapes protect equipment from contamination.
  • 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