Events

Recall of Positron emission / computed tomography X-ray combination imaging device

According to Korean Food & Drug Administration, this recall involved a device in South Korea that was produced by Siemens Hell-Suns Co., Ltd..

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
    879
  • Date
    2018-06-08
  • Event Country
    South Korea
  • Event Terminated Date
    2018-12-08
  • 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
    Number 09-1263

Device

Positron emission / computed tomography X-ray combination imaging device

Manufacturer

Siemens Hell-Suns Co., Ltd.
  • Manufacturer Address
    23, Chungjeong-ro, Seodaemun-gu, Seoul
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    KFDA