Events

Recall of Device Recall da Vinci Si Vision System Cart

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
    65590
  • Event Risk Class
    Class 2
  • Event Number
    Z-1687-2013
  • Event Initiated Date
    2013-06-08
  • Event Date Posted
    2013-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119692
  • 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
    Factory testing on da vinci si surgical systems may not be in compliance with ul standards as one of the testing devices was found to be working incorrectly.
  • Action
    Intuitive Surgical sent an Urgent Device Correction notice dated July 15, 2013, to all affected customers by Federal Express.The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all affected personnel were fully informed of the notification and that the notification should be forwarded to other managers within their facility. Customers were also instructed to complete and return the attached Acknowledgment Form to acknowledge receipt of the notification. Customers with questions were instructed to call Customer Service at 800-876-1310, Option 3. For questions regarding this recall call 408-523-2244.

Device

Device Recall da Vinci Si Vision System Cart
  • Model / Serial
    Part number 380990-11: Serial numbers:  324350 325289 325301 325858 325872 325686 325700 325639 325646 324537 324566 324087 324577 324772 324784 324948 325126 325279 325138 325621 325441 325453 325564 323865 323870 323977 324010 324014 324334.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.
  • Product Description
    da Vinci Si Vision System Cart, model number VS3000; || Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. || Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
  • 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