Events

Device Recall Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems 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
    67030
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0800-2014
  • 사례 시작날짜
    2013-12-17
  • 사례 출판 날짜
    2014-01-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124573
  • 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
    An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.
  • 조치
    The distribution of the Urgent Medical Device Correction letter scheduled to begin on December 17, 2013. ¿x Field service personnel will be notified of the Urgent Medical Device Correction Letter via the Siemens Knowledge Base, as well as information regarding placing labels on the customer system to remind the customer that ///// is not a reportable result. ¿x The Customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue. ¿x Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction.

Device

Device Recall Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems
  • 모델명 / 제조번호(시리얼번호)
    ADVIA 1200 with software versions: V2.00 and V2.01  ADVIA 1650 with software versions V3.52 and V4.01
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution. USA nationwide and the country of Canada.
  • 제품 설명
    Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. || Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA