Events

Device Recall Microstream SMART CAPNOLINE PLUS O2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Oridion Medical 1987 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
    55790
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2007-2010
  • 사례 시작날짜
    2010-05-26
  • 사례 출판 날짜
    2010-07-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91798
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    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 data.
  • 데이터 추가 비고
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code cck
  • 원인
    The microstream filterline may not be recognized by the monitor when connected. no co2 readings will be displayed and no alarms may sound for unmonitored patients. replacing the filterline may delay treatment.
  • 조치
    Oridion notified customers by letter on 5/26/10 and requested that they remove the FilterLines from the related production lots from the field and an immediate replacement with FilterLines from subsequent production lots. Questions are directed to the responsible person at the supplier named in the letter, or to Oridion Capnography at 888-674-3466.

Device

Device Recall Microstream SMART CAPNOLINE PLUS O2
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers from Q0901006 to Q0908223. Produced between January and July 2009,
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,
  • 제품 설명
    Microstream SMART CAPNOLINE PLUS O2 LONG 100 UN || Part Number: 010341 || 010341 || Part Number: 10341
  • Manufacturer
    Oridion Medical 1987 Ltd.

Manufacturer

Oridion Medical 1987 Ltd.
  • 제조사 주소
    Oridion Medical 1987 Ltd., 7 Hamarpe St., P.O. Box 45025, Har Hotzvim Industrial Park, Jerusalem Israel
  • 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
    USFDA