Events

Device Recall Capnostream20 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
    52959
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2232-2009
  • 사례 시작날짜
    2009-06-30
  • 사례 출판 날짜
    2009-09-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84332
  • 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 was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    ventilator monitor - Product Code CCK
  • 원인
    1) the monitor's ability to withstand electrostatic discharge (esd) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze. 2) the unit generates electromagnetic radiation above the limits set by applicable standards for medical devices.
  • 조치
    Oridian sent a letter to all its distributors June 25, 2009, instructing them to gather all the units to be exchanged for factory reconditioned units that have the hardware and software enhancements and meet all performance requirements in full.

Device

Device Recall Capnostream20
  • 모델명 / 제조번호(시리얼번호)
    Software version V 3.0 and earlier.   Part Number Part Description   CS08651, Capnostream20 with Nellcor pulse oximetry module   CS08653 Capnostream20 with Masimo pulse oximetry module   CS08657 Capnostream20 with Nellcor pulse oximetry module and printer   CS08659  Capnostream20 with Masimo pulse oximetry module and printer
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659.
  • 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