Events

AED 20 external automatic defibrillators 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Welch Allyn 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
    2005-06-09
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-defibrillateurs-externes-automatiques-aed-20-de-la-societe-welch-allyn
  • 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
    Afssaps was informed of a recall of AED 20 external automatic defibrillators performed by Welch Allyn on May 17, 2005 due to a risk of device failure leading to a lack of analysis of the patient's electrocardiogram and a defect in treatment of the patient .. The health facilities concerned received the attached mail (09/06/2005) (63 KB). The other European competent authorities have been informed of this measure by the manufacturer. This information concerns the directors of health establishments and the local correspondents of materiovigilance for dissemination to the services concerned.

Device

AED 20 external automatic defibrillators

Manufacturer

Welch Allyn
  • Source
    LAANSM