Device Recall AIRIS II MR System

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers C048 thru C788.
  • 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 II 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
  • 1 Event

제조사

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