Device Recall Irix Gamma Camera

  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: 210857 and 210881.  4535 679 46991, or N210857 Irix System, 3/8" Crystal 4535 665 13551, or N210881 Irix System 3/4" Crystals 4535 679 46981, or N211038 Irix System 3/8 Precision 4535 665 13571, or N211040 Irix System 3/4 Precision (Note: Due to a part number scheme change at the firm, either number is representative of the identified system)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, Puerto Rico and countries of Argentinia, Austrailia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Iceland, India, Ireland, Israel, Italy, Japan, Netherlands, Norway, Philipines, Poland, Singapore, South Africa, Spain, Switzerland, and United Kingdom.
  • 제품 설명
    Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA