Events

AED20 semi-automatic external 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
    2006-12-22
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/alerte-relative-a-des-defibrillateurs-externes-semi-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
    A worldwide recall of AED20 semi-automatic external defibrillators has been implemented due to a risk of dysfunction preventing or delaying unacceptably the delivery of shock by the defibrillator, with a possible failure of the patient's resuscitation. In France, only 20 demonstration devices were concerned by this recall: after multiple searches, 2 devices numbers 205519 and 205520, were not found. As a result and in agreement with Afssaps, the company WELCH ALLYN asks all potential users of these devices, to check if they do not have these 2 serial numbers and to warn if necessary, the company WELCH ALLYN at +33 (0) 1 60 09 33 66. This information is addressed to the directors and pharmacists of health establishments, and to the local correspondents of materiovigilance for dissemination, where applicable to the services concerned. SDIS are also affected by this alert.

Device

AED20 semi-automatic external defibrillators
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Welch Allyn

Manufacturer

Welch Allyn
  • Source
    LAANSM