Events

Device Recall Site Rite Vision Ultrasound System, 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Access Systems 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
    57012
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2782-2011
  • 사례 시작날짜
    2011-06-21
  • 사례 출판 날짜
    2011-07-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101242
  • 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
    Ultrasound System - Product Code IYN
  • 원인
    Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.
  • 조치
    Bard Access Systems, Inc sent out an "Urgent" Medical Device Recall (User Level)" dated June 2011 to all affected customers The letter included: product name, description of problem and requested the return of units bearing "B50" on the fan. Bard Access Systems, Inc. will replace the incorrect fan with the correct fan. For additional information call 1-724-779-3000.

Device

Device Recall Site Rite Vision Ultrasound System,
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: DYUJA023, DYUJA024, DYUJA025, DYUJA026, DYUJA027, DYUJA028, DYUJA029, DYUJA030, DYUJA031, DYUJA032, DYUJA034, DYUJA036, DYUJA037, DYUJA038, DYUJA039, DYUJA040, DYUKA001, DYUKA002, DYUKA003, DYUKA004, DYUKA005, DYUKA006, DYUKA007, DYUKA008, DYUKA009, DYUKA010, DYUKA011, DYUKA012, DYUKA013, DYUKA014, DYUKA015, DYUKA015, DYUKA017, DYUKA018, DYUKA019, DYUKA020, DYVAA001, DYVAA002, DYVAA003, DYVAA004, DYVAA005, DYVAA006, DYVAA007, DYVAA012, DYVAA013, DYVAA014, DYVAA015, DYVAA016, DYVAA017, DYVAA018, DYVAA019, DYVAA020, DYVAA021, DYVAA022, DYVAA023, DYVAA024, DYVAA025, DYVAA026, DYVAA027, DYVAA028, DYVAA029, DYVAA030, DYVAA031, DYVAA032, DYVAA033, DYVAA036, DYVAA037, DYVAA038, DYVAA039, DYVAA040, DYVBA002, DYVBA003, DYVBA004, DYVBA005, DYVBA006, DYVBA007, DYVBA008, DYVBA009, DYVBA010, DYVBA011, DYVBA012, DYVBA013, DYVBA014, DYVBA015, DYVBA018, DYVBA019, DYVBA020.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide (USA) distribution including the states of AL, AR, AZ, CA, CO, FL, IA, IN, MD, MI, MO, MS, NC, NJ, NM, NY, OH, PA, RI, SC, TX, UT, VA, VT, and WA.
  • 제품 설명
    Site Rite Vision Ultrasound System, REF 9770032, || Bard Access Systems, Inc. || Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems
  • 제조사 주소
    Bard Access Systems, 605 North 5600 West, Salt Lake City UT 84116-3738
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA