Events

unkown device 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 N/A 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
    2004-04-08
  • 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-sur-les-lits-medicaux-electriques-equipes-de-pedales-de-commande-de-hauteur-variable
  • 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
    Due to the persistence of reports of serious incidents related to an involuntary activation of a movement of the electric bed by acting on the variable height control pedal, the Afssaps broadcasts the alert attached (08/04 / 2004) (116 KB) at destination. health facility directors and local correspondents for materiovigilance for dissemination to technical, biomedical, purchasing and care services. the Directorate-General for Social Action for dissemination to the directors of institutions for the elderly and disabled. Each establishment must proceed or have the variable height pedals on the electric medical beds inactivated according to the specific protocols established by the manufacturers. The inactivation procedures that were provided to us by the manufacturers are available from the list below. The other competent European authorities have been informed of this measure. . List of manufacturers distributing in France beds equipped with variable height control pedals. updated: 13/05/0. To obtain the protocol (pdf format), click on the name of the manufacturer. . WORKSHOPS OF UPPER FOREZ (01/01/1970) (0 KB MATIFAS (07/04/2004) (2329 KB CORONA (14/04/2004) (615 KB MEDICATLANTIC (13/04/2004) (151 KB EDENA (13/04/2004) (1629 KB) MEYRA - no product distributed in English HILL-ROM (14/04/2004) (2972 KB MMO (08/04/2004) (1146 KB) EST ( 07/04/2004) (4554 KB SOTEC (08/04/2004) (118 KB MALVESTI TASSERIT (13/05/2004) (8 KB)

Device

unkown device
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    LAANSM