Device Recall Symbiq One Channel Infuser 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hospira 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
    64005
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0361-2017
  • 사례 시작날짜
    2011-03-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-11-28
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
    Pump, infusion - Product Code FRN
  • 원인
    May go to a white screen due to a problem with the som2 module. a white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. the infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. delay or interruption of therapy.
  • 조치
    Hospira sent an Urgent Device Recall Letters, dated February 5, 2013, to all affected customers. Customers were directed to notify their consignees if they further distributed the product and confirm they have done so by return of the reply form. Healthcare professionals were to contact Stericycle. Hospira discontinued support of these devices as of June 30, 2015. Customers with questions were instructed to call 1-800-201-9064. For questions regarding this recall call 224-212-4892.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Canada
  • 제품 설명
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. || The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • 제조사 모회사 (2017)
  • Source
    USFDA