Events

Device Recall Fukuda Denshi patient monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fukuda Denshi USA, Inc. 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
    72953
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0661-2016
  • 사례 시작날짜
    2015-12-21
  • 사례 출판 날짜
    2016-01-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142581
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    A possible malfunction where a short-term battery error message has appeared and has been traced back to a bad (damaged) lithium-ion capacitor (short-term backup battery).
  • 조치
    Fukuda Denshi USA, Inc. of Redmond, WA plans to perform 100% field correction of units distributed in the US. The Recall/Field Correction Notice letter (FCN-A01-201512), dated December 21, 2015, and the Customer Confirmation Sheet will be sent to consignees using a clearly red-marked URGENT via Express Mail. The consignees are requested to fill out the Customer Confirmation Sheet and return via fax to 888-224-7090, email to DBlakely@fukuda.com, or send via postal service back to Fukuda Denshi USA, Inc. in a pre-stamped envelope. Consignee can call Doug Blakey directly at 210-240-4521 with any questions or concerns.

Device

Device Recall Fukuda Denshi patient monitor
  • 모델명 / 제조번호(시리얼번호)
    50400001, 50400002, 50400003, 50400004, 50400011, 50400012, 50400018, 50400019, 50400020, 50400021, 50400022, 50400023, 50400024, 50400025, 50400026, 50400027, 50400028, 50400029, 50400030, 50400031, 50400032, 50400033, 50400034, 50400035, 50400036, 50400037, 50400038, 50400039, 50400040, 50400042, 50400043, 50400044, 50400045, 50400046, 50400047, 50400048, 50400049, 50400050, 50400051, 50400052, 50400053, 50400054, 50400055, 50400056, 50400057, 50400058, 50400059, 50400060, 50400061, 50400062, 50400063, 50400064, 50400065, 50400066, 50400067, 50400068, 50400069, 50400070, 50400071, 50400072, 50400073, 50400074, 50400075, 50400076, 50400077, 50400078, 50400084, 50400093, 50400094, 50400095, 50400096, 50400097, 50400098, 50400099, 50400100, 50400101, 50400102, 50400103, 50400104, 50400105, 50400106, 50400107, 50400108, 50400109, 50400110, 50400111, 50400112, 50400113, 50400114, 50400115, 50400116, 50400117, 50400118, 50400119, and 50400120.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.
  • 제품 설명
    Fukuda Denshi patient monitor model DS-8100M and DS-8100N. || The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is || meant to acquire and monitor physiological signals from patients.
  • Manufacturer
    Fukuda Denshi USA, Inc.

Manufacturer

Fukuda Denshi USA, Inc.
  • 제조사 주소
    Fukuda Denshi USA, Inc., 17725 NE 65th St Ste C, Redmond WA 98052-4911
  • 제조사 모회사 (2017)
    Fukuda Denshi Co., Ltd.
  • Source
    USFDA