GEM II DR 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 MEDTRONIC OF CANADA LTD. 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
  • 사례 ID
    48621
  • 사례 위험등급
    II
  • 사례 시작날짜
    2000-02-16
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Loss of telemetry and device output because of fractured solder joint.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 7273 (Lot serial: PJK200606H PJK200989H); Model Catalog: 7273 (Lot serial: PJK202209H PJK200857H); Model Catalog: 7273 (Lot serial: PJK200853H PJK201834H); Model Catalog: 7273 (Lot serial: PJK200322S PJK200611H); Model Catalog: 7273 (Lot serial: PJK200174H PJK200214H); Model Catalog: 7273 (Lot serial: PJK200743S PJK201835H); Model Catalog: 7273 (Lot serial: PJK200522S PJK200607H); Model Catalog: 7273 (Lot serial: PJK200346S PJK200521S); Model Catalog: 7273 (Lot serial: PJK200762S PJK200768S); Model Catalog: 7273 (Lot serial: PJK200415S PJK200305S); Model Catalog: 7273 (Lot serial: PJK201838H PJK201883H); Model Catalog: 7273 (Lot serial: PJK200424S PJK201837H); Model Catalog: 7273 (Lot serial: PJK200520S PJK201922H); Model Catalog: 7273 (Lot serial: PJK200310S PJK200524S); Model Catalog: 7273 (Lot serial: PJK200526S PJK200528S); Model Catalog: 7273 (Lot serial: PJK201815H PJK202178H); Model Catalog: 7273 (Lot serial: PJK200323S PJK200696S)
  • 제품 설명
    GEM DR II
  • Manufacturer

Manufacturer

  • 제조사 주소
    BRAMPTON
  • 제조사 모회사 (2017)
  • 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
    HC