Events

Midas Rex Classic, GS and Legend 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Medtronic France 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
    2005-09-12
  • 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-de-lots-d-outils-de-dissection-midas-rex-classic-gs-et-legend-medtronic
  • 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
    MEDTRONIC Powered Surgical Solutions has withdrawn from the market on September 8, 2005, the batches manufactured before April 2004, medical devices called "disposable dissection tools (strawberries) single-use Midas Rex Classic, GS and Legend" following the risk of packaging brittle observed after 30 months of expiry; as a result, all lots older than 18 months, ie with an expiry date from September 2005 to March 2009, are withdrawn from the market. The company has directly notified the recipients of the incriminated lots using of the message attached (08/09/2005) (47 KB) validated by Afssaps .. For the products not concerned by the recall, the expiry time has been reduced to 30 months and the batch number has been underlined to identify them .. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Midas Rex Classic, GS and Legend
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Medtronic France

Manufacturer

Medtronic France
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    LAANSM