Events

Device Recall Dimension Vista 500 Intelligent Lab System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics 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
    73885
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1885-2016
  • 사례 시작날짜
    2016-03-24
  • 사례 출판 날짜
    2016-06-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145310
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • 원인
    Discrepant patient results on dimension vista intelligent lab systems. siemens healthcare confirmed a software defect which, in a very specific set of circumstances, results in the dimension vista system omitting an aliquot probe rinse between sample aspirations when processing tubes in sample racks that are front loaded on the dimension vista system.
  • 조치
    Siemens sent an Urgent Medical Device Correction letter dated March 24, 2016, to all affected customers. Customers were advised to follow the instructions contained in the "Urgent Medical Device Correction" notification letter to help minimize or eliminate the impact that this specific software defect could cause until a software correction could be made (i.e instructions to minimize the impact of the software defect due to "Bad Sample Detect " False Transition" errors when processing front loaded samples) and (how to eliminate the impact of the software defect when processing front loaded samples). Customers were also asked to review the recall notification letter with their Medical Director and complete and return the Field Correction Effectiveness Check Form within 30 days. Customers with questions were advised to contact Siemens Customer Care Center - Technical Solutions at 800-441-9250 or their local Siemens technical support representative. For questions regarding this recall call 302-631-8248.

Device

Device Recall Dimension Vista 500 Intelligent Lab System
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers are affected.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, , ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.
  • 제품 설명
    Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. || The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics Inc., 101 Silvermine Rd, Brookfield CT 06804-2047
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA