Events

ConMed Linvatec Convertible LightWave Ablators 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 ConMed Linvatec 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
    2009-08-18
  • 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-des-lots-du-dispositif-medical-ablateurs-lightwave-a-aspiration-conmed-linvatec
  • 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
    On 14/08/2009, ConMed Linvatec France has withdrawn from the market all the batches of the reference IA-2000-S mentioned in the appendix of the medical device recall letter called: ConMed Linvatec Convertible LightWave Ablators, manufactured by ConMed Linvatec in the USA. As a result of claims in the United States, ConMed Linvatec has determined the possibility for the medical device to not shut down when releasing the interrupt button. The malfunction may result in injury to the patient or the user. The company ConMed Linvatec France has directly notified the recipients of the offending lots with the enclosed message validated (18/08/2009) (25 KB) by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The competent European authorities concerned have been informed of this measure by ConMed Linvatec.

Device

ConMed Linvatec Convertible LightWave Ablators
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    ConMed Linvatec

Manufacturer

ConMed Linvatec