Events

Recall of 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
    37431
  • Event Risk Class
    Class 2
  • Event Number
    Z-0670-2007
  • Event Initiated Date
    2006-04-12
  • Event Date Posted
    2007-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50544
  • 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 Instrument Control System - Product Code NAY
  • Reason
    Da vinci s surgical system's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique.
  • Action
    The firm did not release notification to its consignees. The reworks were arranged as part of routine service visits initiated on 4/12/06.

Device

Da Vinci S Surgical System
  • Model / Serial
    System Numbers:  SG011, SG012, SG013, SG014, SG017, SG018, SG019, SG020, SG058, and SG094.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm; Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

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