Events

Device Recall Biograph Mobile 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA 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
    76228
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1423-2017
  • 사례 시작날짜
    2017-02-20
  • 사례 출판 날짜
    2017-02-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-09-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152551
  • 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, tomography, computed, emission - Product Code KPS
  • 원인
    The mobile-specific instructions was not shipped to a limited population of biograph mobile systems.
  • 조치
    Siemens sent a Customer Advisory Notice letter on February 20, 2017 to affected customer. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens.

Device

Device Recall Biograph Mobile
  • 모델명 / 제조번호(시리얼번호)
    1010, 1015, 1034, 1044, 45503, 45537
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution - US Nationwide in the states of CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY and the countries of Switzerland, Great Britain, Italy
  • 제품 설명
    Biograph 6 TruePoint, Material Number 10097290 || The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: || ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and || ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
  • Manufacturer
    Siemens Medical Solutions USA Inc.

Manufacturer

Siemens Medical Solutions USA Inc.
  • 제조사 주소
    Siemens Medical Solutions USA Inc., 810 Innovation Dr, Knoxville TN 37932-2562
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA