Events

Cardiovascular stents 의 리콜

Korean Food & Drug Administration에 따르면, 해당 리콜 는 South Korea 에서 Biotronic Korea Co., Ltd. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    321
  • 날짜
    2015-07-07
  • 사례 국가
    South Korea
  • 사례 출처
    KFDA
  • 사례 출처 URL
    https://emed.mfds.go.kr
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    No. 13-1048

Device

Cardiovascular stents

Manufacturer

Biotronic Korea Co., Ltd.
  • 제조사 주소
    344 Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do
  • 제조사 의견
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    KFDA