Events

Recall of DA VINCI SI SYSTEM - MAIN

According to Health Canada (via FOI), this recall involved a device in Canada 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
    87455
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-06
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Labelling updates to distributed user manuals instructions for use quick reference guides and instrument release kit for use with da vinci surgical systems and instruments and accessories. updates have been implemented to incorporate user feedback not previously addressed.

Device

DA VINCI SI SYSTEM - MAIN
  • Model / Serial
    Model Catalog: IS3000 (Lot serial: all lots. contact mfg); Model Catalog: IS1200 (Lot serial: all lots. contact mfg); Model Catalog: IS2000 (Lot serial: all lots. contact mfg)
  • Product Description
    Da Vinci Si System - Main
  • Manufacturer
    INTUITIVE SURGICAL INC.

Manufacturer

INTUITIVE SURGICAL INC.