CardioTek EPTracer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 CardioTek BV 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
    77025
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2657-2017
  • 사례 시작날짜
    2017-04-13
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • 원인
    Software bug which allows parameters to be changed unintentionally during use.
  • 조치
    The Firm, Schwarzer cardiotek, sent an "Urgent Field Safety Notice" dated 4/21/2017 to its consignees. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following: " While backup pacing is active the software must not be operated. " In case of backup pacing disconnect all catheter connection pins and reconnect only the two required for stimulation to the dedicated backup pacing output ports (OUT1 or OUT2). " If the backup pacing parameters were changed by accident quickly switch backup pacing off and on again to reset the parameters. " Ensure that the system is only operated by trained users. The firm plans to do the following: " provide an amendment to the hardware manual concerning the correct use of the backup pacing functionality to all service partners and customers. An updated software, which prevents accidental change of backup pacing parameters will be made available. Upon receipt of the amendment and installation of the software update, the completed feedback form must be returned to CardioTek no later than 3/4/2018 by fax +49 7131 2774 590 or email: Service@schwarzercardiotek.com. If you have any questions, please contact Sales & Service at +49 172 790 9112 or email: Service@schwarzercardiotek.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    All EP-Tracer -FSCA-identifier (2017-04-06)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) to states of: CA, IL, OH, and MN; and countries of: Albania, Algeria, Argentina, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cuba, Czech Rep, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Monaco, Morocco, Netherlands, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Rep. Dominicana, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad & Tobago, Turkey, United Arab Emirates, United Kingdom, Venezuela and Vietnam.
  • 제품 설명
    CardioTek EP-TRACER Software V1.x and V2.0 || The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
  • Manufacturer

Manufacturer

  • 제조사 주소
    CardioTek BV, Amerikalaan 70, Maastricht-Airport Netherlands
  • Source
    USFDA