Device Recall AIRIS MR System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hitachi Medical Systems America 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
    34060
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0428-06
  • 사례 시작날짜
    2005-12-01
  • 사례 출판 날짜
    2006-01-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-10-29
  • 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, Nuclear Magnetic Resonance Imaging - Product Code LNH
  • 원인
    The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.
  • 조치
    The recalling firm sent a recall/field correction letter, dated 12/1/05 to all consignees.

Device

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers A305 thru A341.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The devices were distributed to FL, WA, IL, TX, NC, NY, OH, CO, LA, NJ, CA, AZ, SC, AR, OK, MN, SD, OR, PA, AL, GA, MD, MS, MO, CT, WI, KY, IN, KS, MA, DE, IA, UT, TN, VA, ID, NE, ND, NV, Puerto Rico, and to St. Thomas, Virgin Islands.
  • 제품 설명
    The AIRIS MR System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagital, oblique, and curved cross-sectional images that display the internal structure of the head, body, and extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance and proton density, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
  • 제조사 모회사 (2017)
  • Source
    USFDA