Events

Recall of Device Recall daVinci

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
    65094
  • Event Risk Class
    Class 2
  • Event Number
    Z-1424-2013
  • Event Initiated Date
    2013-01-24
  • Event Date Posted
    2013-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117872
  • 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
    Change to user manual to remove one indication for use and amend warnings to emphasize restrictions for use.
  • Action
    Intuitive sent an Important Medical Device Correction letters dated January 24, 2013 via Federal Express to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate and discard the existing TORS addendum, place the new TORS addendum included with this letter with your System User Manual, and complete and return the attached Acknowledgement Form to Intuitive Surgical. For questions call Intuitive Surgical Customer Service at 1-800-876-1310.

Device

Device Recall daVinci
  • Model / Serial
    Model number 552002-01
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution Only
  • Product Description
    User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. || Product Usage: || The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.
  • 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