Device Recall Biograph mCT X4R 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
    76127
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0994-2017
  • 사례 시작날짜
    2016-12-13
  • 사례 출판 날짜
    2017-01-10
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-05-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Siemens medical solutions, molecular imaging has become aware, through our supplier that some laser cover windows may fall off.
  • 조치
    Siemens Healthineers sent a Customer Safety Advisory Notice letter on December 13, 2016. The letter states that the light marker windows used for the positioning laser and integrated into the front cover of the Biograph mCT or Biograph mCT Flow system may loosen and potentially drop out and warning the consignee not to use the system of the front cover is loose or missing. Customers with questions were instructed to contact their local Siemens representative at the following numbers: America 1-800-888-7436 Europe, Middle East and Africa +49 9131 940 4000 Asia and Australia +86 (21) 3811 2121 For questions regarding this recall call 865-218-2000.

Device

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 1008, 11016, 11017, 11022, 11029, 11036, 11054, 11066, 1010, 1004, 11063, 11027, 11055, 11056, 11058, 11057, 11060, 11064, 11070, 21074, 1003, 1005, 1009, 11015, 11023, 11037, 11042, 11045, 11047, 11052, 11059, 11065, 11031, 1002, 11061, 11068, 1006, 11019, 11041, 11048, 11038, 11039, 11014, 11021, 11028, 11030, 11034, 11069, 21071, 11018, 11013, 11040, 11067, 11025, 11049, 11051, 11050, 11046, 11062, 1007, 1011, 11012, 11020, 11024, 11026, 11035, 11043, 11044, 21072, 21073, 1001
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.
  • 제품 설명
    Biograph mCT X-4R, Material Number 10248670 || The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
  • Manufacturer

Manufacturer

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