Events

Recall of Electrode for reusable foot-operated electrosurgical instrument, electrode for reusable foot-operated electrosurgical instrument

According to Korean Food & Drug Administration, this recall involved a device in South Korea that was produced by Intuitive Surge Korea.

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
    932
  • Date
    2018-08-28
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-28
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, 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 South Korea.
  • Extra notes in the data
    14-448, 14-2583

Device

Electrode for reusable foot-operated electrosurgical instrument, electrode for reusable foot-oper...

Manufacturer

Intuitive Surge Korea
  • Manufacturer Address
    Seongam Ro 330, Mapo-gu, Seoul
  • Manufacturer Parent Company (2017)
    Intuitive Surgical Inc
  • Source
    KFDA