Events

Recall of Device Recall da Vinci S 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
    46716
  • Event Risk Class
    Class 2
  • Event Number
    Z-1180-2008
  • Event Initiated Date
    2007-12-27
  • Event Date Posted
    2008-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68034
  • 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
    endoscopic surgical control system - Product Code NAY
  • Reason
    Delay in responding: in certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control.
  • Action
    Beginning 12/28/2007, Intuitive Surgical Field Service Representatives visited each site to correct the issues. A notification letter was provided to all sites.

Device

Device Recall da Vinci S Surgical System
  • Model / Serial
    Model number IS2000, Revision AP51 P5, System numbers SG015, SG020, SG040, SG103, SG152, SG169, SG179, SG213, SG215, SG355, top level part numbers 380267-01, 380431-02, and 380431-05
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Distribution: TX, NJ, WA, NV, HI, MI, NH and CA
  • Product Description
    da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Manufacturer Address
    Intuitive Surgical, Inc., 950 Kifer Rd, Sunnyvale CA 94086-5206
  • Source
    USFDA