Events

Recall of Low-power cardiopulmonary

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

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
    30
  • Date
    2014-03-28
  • Event Country
    South Korea
  • 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
    Accepted 04-529

Device

Low-power cardiopulmonary
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Instruments used to remove an atrial or ventricular fibrillation by directing an electrical shock to the heart, either directly or through an electrode placed on the chest wall (a device with a maximum output power of less than 360J at a test load of 50◦)
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Seoul, Korea 272
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    KFDA