Events

Device Recall Edwards' MHANM8 Pressure Slave Cable 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Edwards Lifesciences, Llc 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
    56148
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0160-2011
  • 사례 시작날짜
    2010-06-25
  • 사례 출판 날짜
    2010-10-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92746
  • 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 pre-programmed, single-function - Product Code DXG
  • 원인
    The recall was initiated because the edwards' mhanm8 pressure slave cable was wired incorrectly, thus will not work as stated.
  • 조치
    Edwards Lifesciences contacted customers via telephone on June 22, 2010 informing them of the product, the problem and the action they should take. Customers were asked to locate their cables and send them back overnight using the provided Edwards FedEx account number. Edwards Lifesciences indicated their personnel would follow-up with each customer until all units were returned. For any questions regarding this recall call (949) 250-2007.

Device

Device Recall Edwards' MHANM8 Pressure Slave Cable
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 58822824; 58821774
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand
  • 제품 설명
    Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 || The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.
  • Manufacturer
    Edwards Lifesciences, Llc

Manufacturer

Edwards Lifesciences, Llc
  • 제조사 주소
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA