Device Recall Digital Imager, Radiation Therapy

  • 모델명 / 제조번호(시리얼번호)
    151055, 151700, 151809, 151695, 151479, 151696, 151867, 151704, 151765, 151860, 151024, 151521, 151803, 152217, 151774, 152220, 151626, 151842, 151847, 151446, 151801, 151953, 151664, 151751, 151352, 151298, 151728, 151504, 151981, 151705, 151977, 152123, 152126, 151955, 105982, 151160, 151634, 151954, 151416, 151074, 151587, 151729, 151694, 151965, 151418, 151674, 151259, 151698, 151699, 152043, 151636, 151811, 151568, 151258, 151584, 151423, 151623, 151627, 151507, 151640, 151933, 151340, 151722, 151810, 151051, 151411, 151360, 151595, 151433, 151611, 152008, 151151, 151714, 151653, 151675, 151538, 152031, 151523, 151519, 151432, 151783, 151410, 151371, 151084, 151387, 151978, 151530, 151328, 151689, 151567, 151598, 151760, 151269, 151557, 151558, 151789, 151398, 151632, 152214, 151301, 151441, 151256, 151391, 151038, 151585, 151327, 151326, 151250, 151130, 151828, 151245, 151672, 105803, 151073, 151956, 152232, 151319, 151959, 151960, 151958, 151435, 151779, 151969, 151848, 151875, 151881, 151882, 151736, 152023, 152080, 152079, 152064, 151734, 151763, 152154, 151110, 151363, 151216, 151173, 151678, 151467, 151961, 151178, 152091, 152051, 152115, 152116, 151708, 152176, 152192, 152098, 152200, 152174, 152246, 152364, 152673, 152425, 151156, 151764, 151886, 151076, 151369, 152175, 105941
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution-DC, Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI.
  • 제품 설명
    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 || Used as part of radiation therapy treatment process.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
  • 제조사 모회사 (2017)
  • Source
    USFDA