Events

Device Recall Dimension Vista LOCI Reaction Vessel 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
    54039
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0980-2010
  • 사례 시작날짜
    2009-11-24
  • 사례 출판 날짜
    2010-03-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87271
  • 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
    Some vessels may leak. if leakage occurs, patient results will be flagged and are not reportable.
  • 조치
    The recalling firm issued an Urgent Field Safety Notice dated 11/2009 to all affected customers. Customers have been told to discard any bags of the affected lot. If the affected lot is the only lot the customer has, customers can examine a vessel from the bag. If the vessel mold cavity identity is B8, customers should discard the bag. Thus customers can use the lot if the cavity mold is anything other than B8. In addition, customers have been told to empty the LOCI vessel holder on all systems and to discard vessels in case any affected vessels have been loaded onto the system. For technical questions or concerns, please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance.

Device

Device Recall Dimension Vista LOCI Reaction Vessel
  • 모델명 / 제조번호(시리얼번호)
    Catalog number KS855. Lot number NH29-188-09
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The device was shipped to medical facilities in CA, CO, FL, GA, IL, LA, MD, MI, MS, NE, NC, NJ, NY, OH, SC, TN, TX, VA, WA, and WI. The product was also shipped to Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, and Switzerland.
  • 제품 설명
    Dimension Vista LOCI Reaction Vessel
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA