Events

Segufix support belts 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Adhésia Laboratoire 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
    2004-07-28
  • 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-ceintures-de-maintien-segufix-par-la-societe-adhesia-laboratoire
  • 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
    In agreement with AFSSAPS, Adhésia Laboratoire is recalling the Segufix support belts, references SG00, SG01 and SG 02, which are not equipped with lateral straps attached to the belt following several serious incidents of materiovigilance. The users of these seat belts were informed on 26 July 2004 of this reminder by the attached letter (26/07/2004) (194 KB). This recall follows a notification by the competent German authority ( Bfarm) .. This information concerns the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services in particular the services of geriatrics and psychiatry.

Device

Segufix support belts
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Adhésia Laboratoire

Manufacturer

Adhésia Laboratoire
  • Source
    LAANSM