Events

BD Phoenix Automated Microbiology System Software for Automated Microbiological System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & Co. 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
    61692
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1657-2012
  • 사례 시작날짜
    2012-04-10
  • 사례 출판 날짜
    2012-05-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108724
  • 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
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • 원인
    Bd identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all pmic or pmic/id panels and could lead to ineffective treatment regimen in affected patients.
  • 조치
    Becton Dickinson (BD) sent an Urgent Field Correction Action letter dated April 2012 and an Update letter dated April 18, 2012 to all affected customers via e-mail and UPS overnight delivery. The letter identified the affected products, problem and actions to be taken. The letter provided specific workaround instructions for device users pending software upgrades. A BD Service Engineer will contact affected customers to arrange for the installation of the updated software when it becomes available. The letter included an Acknowledgement Form to be completed. For questions contact Technical Services at 800-638-8663.

Device

BD Phoenix Automated Microbiology System Software for Automated Microbiological System
  • 모델명 / 제조번호(시리얼번호)
    Software versions: 5.55R, 5.66A, 5.70A, 5.75A, 5.83A, and 6.01A
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT ,DC ,FL , GA, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, AND WY. and the countries of Canada, Australia, Philippines, Thailand, Malaysia, India, New Zealand, Belgium, Singapore, Japan, Taiwan, China, Chile, Colombia, Korea, Brazil and Venezuela.
  • 제품 설명
    Becton Dickinson Phoenix System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. || Product Usage: || Automated Microbiology System for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Positive bacteria from pure culture.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • 제조사 주소
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA