Events

Acrobat Stabilizer-Vacuum System 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Edwards Lifesciences 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
  • 날짜
    2006-12-18
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-systeme-stabilisateur-aspirateur-acrobat-de-la-societe-guidant-boston-scientific
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • 데이터 추가 비고
  • 조치
    The company Edwards Lifesciences has withdrawn from the market on December 15, 2006 the batches between 4120181 and 6100281 of the medical device called "Acrobat stabilizer-vacuum system" references OM9000S, OM9100S and XO49000S manufactured by GUIDANT-BOSTON Scientific Cardiac Surgery following a highlighting Vacuum leakage may result in partial loss of suction force during 2-year aging tests. As a result, the expiration is changed from 2 years to one year .. This device is used in cardiac surgery. The company has directly notified the recipients of the incriminated lots with the message attached (18/12/2006) (35 ko) validated by the Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary with the services concerned .. The competent European authorities concerned are informed of this measure by the manufacturer.

Device

Acrobat Stabilizer-Vacuum System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Edwards Lifesciences

Manufacturer

Edwards Lifesciences