Events

Peripheral stent Pulsar-18 with delivery system 의 리콜

Federal Service for Surveillance in Healthcare에 따르면, 해당 리콜 는 Russian Federation 에서 BIOTRONIK AG 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
    01И-1129/15, ФСЗ 2011/10641
  • 날짜
    2015-07-10
  • 사례 출판 날짜
    2015-07-22
  • 사례 국가
    Russian Federation
  • 사례 출처
    FSSH
  • 사례 출처 URL
    http://www.roszdravnadzor.ru/services/unreg
  • 비고 / 경고
    Russian data is current through January 2019. All of the data comes from the Federal Service for Surveillance in Healthcare, 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 Russia.
  • 데이터 추가 비고
    Manufacturer Recall

Device

Peripheral stent Pulsar-18 with delivery system
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    BIOTRONIK AG

Manufacturer

BIOTRONIK AG
  • 제조사 모회사 (2017)
    Ms Holding Ii Se
  • 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
    FSSH