Events

Insignia, Contak Renewal TR2 and Vitality 2 models 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Guidant 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
    2006-08-07
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/informations-complementaires-au-retrait-des-stimulateurs-et-defibrillateurs-cardiaques-implantables-de-la-societe-guidant
  • 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
    GUIDANT has withdrawn from the market on July 3, 2006 certain implantable cardiac stimulators and defibrillators of Insignia, Contak Renewal TR2 and Vitality 2 models following recent incidents that revealed the failure of a low-voltage capacitor, leading to a risk of malfunction of these devices. . This withdrawal was accompanied by recommendations for monitoring implanted patients. The company has directly notified the physicians who follow up patients with these devices, using the attached message. validated by Afssaps. Afssaps was informed that the company Guidant had published on August 2, 2006 an update of this information (03/08/2006) (37 KB) stating that other serial numbers were affected by the information broadcast on July 3. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The European competent authorities concerned are informed of this measure by the manufacturer.

Device

Insignia, Contak Renewal TR2 and Vitality 2 models
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Guidant

Manufacturer

Guidant
  • Source
    LAANSM