Events

Device Recall Alaris PC Unit, Model 8000, Infusion Pump power supply board part Part No. TC10005092. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 CareFusion 303, 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
    73315
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1239-2016
  • 사례 시작날짜
    2016-02-12
  • 사례 출판 날짜
    2016-03-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143857
  • 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
    Dressing, wound, drug - Product Code FRO
  • 원인
    Carefusion is recalling the alaris pc unit because a component on the pc unit power supply may cause a "system error" or "missing battery" error code (120.4630).
  • 조치
    A customer notification letter dated 2/25/16 will be sent to all their customers who purchased the Alaris PC unit (Model 8000) to inform them that CareFusion is recalling it because a component on the PC unit power supply board may cause a "System Error" or "Missing Battery" error code (120.4630). The letter informs the customers of the potential risk involved and the actions to be taken. Customers with recall related questions are instructed to call CareFusion Support Center at (888) 562-6018, 7am-4pm PST, Mon-Fri or email at supportcenter@carefusion.com. Customers with clinical inquires, product complaints or clinical troubleshooting are instructed to contact customer advocacy at (888) 812-3266, 24 hrs/day, 7 days/wk or email at customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris system are instructed to contact technical support at (888) 812-3229, 6am-5pm PST, Mon-Fri or email at DL-US-INF-TechSupport@carefusion.com.

Device

Device Recall Alaris PC Unit, Model 8000, Infusion Pump power supply board part Part No. TC10005...
  • 모델명 / 제조번호(시리얼번호)
    Serial No. 4044845 9950535 4064411 12475162 4045659 9899143 3606478 4021398 4093501 4043745 4063430 4094994 9907675 9945292 9922622 4043375 12409069 4020663 12498854 4044531 4058193 12351849 4064030 9925068 12426138 4063830 4063911 9945269
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide in US: AR, AZ, CA, FL, GA, IN, KY, MD, MI, MN, MO, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, WI.
  • 제품 설명
    Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
  • Manufacturer
    CareFusion 303, Inc.

Manufacturer

CareFusion 303, Inc.
  • 제조사 주소
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA