Events

Device Recall Horizon Cardiology Hemo Monitoring System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 McKesson Provider Technologies - Medical Imaging Group 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
    55597
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1899-2010
  • 사례 시작날짜
    2010-01-27
  • 사례 출판 날짜
    2010-06-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-06-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91248
  • 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
    Mckesson has identified a potential hardware configuration problem in some horizon cardiology hemo systems which may cause delay and/or loss of the patient's physiological parameters on the horizon cardiology hemo screen and on the patient record.
  • 조치
    The firm, McKesson Israel Ltd., sent notification letter dated January 27, 2010 to customers. The letter describes the product, problem and action to be taken by customers and the firm. McKesson's will be contacting the customer to coordinate replacement of the sound component of the Horizon Cardiology Hemo system and will provide the additional sound adapter for all affected systems at your facility at not cost. The customers were instructed to pleasel immediately conduct the following instructions to disable sound operations-1) Open McKesson Management Console and locate the Windsurfer>Monitor Settings; 2) Uncheck "Enable QRS beep" in the sounds section; 3) Locate Windsufer>Hardware Settings in McKesson Management Console, and 4) Uncheck "Enable QRS beep" in the Analog Output, QRS Beep Section. If you have any questions, please do not hesitate to contact Ronen Gans directly at (973) 355-9900.

Device

Device Recall Horizon Cardiology Hemo Monitoring System
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 2008052847, 2008072107, 2008092609, 2008092608, 2009010800, 2008121714, 2008101609, 2008101608, 2008101618, 2008110391, 2008110390, 2008110389, 2009020226, 2009020227, 2009030603, 2009030602, 2009030601, 2009110399, 2008110398, 2008051520, 2008051519, 2008051518.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: CA, CT, FL, LA, NC, TN, WA, and WV.
  • 제품 설명
    Horizon Cardiology Hemo Monitoring System || A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.
  • Manufacturer
    McKesson Provider Technologies - Medical Imaging Group

Manufacturer

McKesson Provider Technologies - Medical Imaging Group
  • 제조사 주소
    McKesson Provider Technologies - Medical Imaging Group, 1639 State Rt 10 Ste 100, Parsippany NJ 07054-4506
  • 제조사 모회사 (2017)
    Mckesson Corporation
  • Source
    USFDA