Hitachi Medical Systems America Inc

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 28 건

  • 모델명 / 제조번호(시리얼번호)
    17 21 32 37 38 39 41 43 45 46 48 57 58 59 61 63 64 69 73 77 78 81 82 86 87 92 96 97 99 107 108 109 114 115 116 118 120 121 122 126 129 130 132 135 139 140 141 143 144 147 148 151 155
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in 21 states: AR, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NY, OK, OR, PA, SC, TX, VA, WA, WV.
  • 제품 설명
    Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 11743701 to 11743705  11837701 to 11837705  11906701 to 11906705  12006701 to 12006710  12124701 to 12124710  12315701 to 12315705  12427801 to 12427805
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution --- including states of OH, FL, CA, TX, DE, VA, NY, MO, KS, NJ, MD and ID.
  • 제품 설명
    EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information.
  • 모델명 / 제조번호(시리얼번호)
    Units were distributed nationwide from 05/23/2001 to 12/07/2007. If you have questions concerning this action, contact Douglas J. Thistlethwaite at (800) 800-3106 x3720.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The recalled device units were distributed to customers located in the following states nationwide: CA, OH, IL, NJ, NY, FL, TX, NE, AR, MD, OR, MN, NV, MS, OK, IN, TN, MO, SC, VA, HI, LA, NC, NM, WY, WA, AL, PA, UT, WA, and KY
  • 제품 설명
    Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with physiological and clinical information obtained non-invasive and without the use of ionizing radiation.
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 203, 303, 305, 307, 308, 309, 310, 311, 312, 313, 314, 315, 316, 317, 318, 319, 320, 321, 323, 325, 326, 327, 328, 329, 330, 332, 333, 335, 336, 337, 338, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 350, 351, 352, 353, 354, 355, 356, 357, 359, 360, 361, 362, 363, 364, 365, 366, 367, 368, 369, 370, 371, 372, 373, 374, 375, 377, 378, 379, 380, 381, 382, 383, 384, 385, 386, 387, 388, 389, 390,, 391, 392, 393, 394, 395, 396, 397, 398, 399, 400, 401, 402,, 403, 404, 405, 406, 407, 408, 410, 411, 412, 413, 414, 415 416, 417, 418, 419, 420, 421, 422, 424, 425, 426, 427, 429, 430, 431, 432, 434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 445, 446, 447, 449, 450, 451, 452, 453, 454, 456, 457, 458, 460, 461, 462, 463, 464, 465, 466, 467, 468, 469, 470, 472, 473, 474, 475, 476, 477, 478, 479, 480, 481, 482, 483, 485, 486, 487, 488, 489, 491, 492, 493, 494, 495, 496, 497 499, 501, 502, 503, 504, 505, 509, 510, 512, 513, 514, 515 516, 517, 518, 519, 520, 521, 522, 523, 524, 527, 528, 529 530, 531, 532, 533, 534, 535, 536, 537, 538, 539, 540, 541, 542, 543, 544, 545, 546, 547, 548, 549, 550, 551, 552, 553, 554, 555, 556, 557, 559, 560, 561, 562, 563, 564, 565, 566, 567, 568, 570, 571, 572, 573, 574, 575, 576, 577, 578, 579, 580, 581, 582, 583, 584, 585, 586, 587, 588, 589, 590, 591, 592, 593, 594, 595, 596, 597, 598, 599, 600, 601, 602, 603.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide: U.S. A. to include: AL, AR, AZ, CA, CO, CT, DE, FL, HI, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, & WY.
  • 제품 설명
    Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive only coil that functions at 29.641 MHz band. It consists of a cable and a coil (imaging) body. A portion of the cable is referred to as the balun assembly or balun trap. The shoulder coil assembly is packaged in a cardboard box with foam inserts.
  • 모델명 / 제조번호(시리얼번호)
    The following serial numbers are associated with this recall: Echelon - V061, V062, and V065 Oasis - M009, M017, M067, M071, M084, M106-M108, M110-M141 inclusive, and M952 Echelon Oval - Y001-Y005 inclusive
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DE, FL, IL, IN, KS, KY, MD, NC, ND, NY, OH, OR, PA, TX, VA, WA, and WI. One (1) system unit was also distributed to Mexico.
  • 제품 설명
    Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. || The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR systems produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities.
하나 더 23 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Hitachi Medical Systems America Inc, 1995 Summit Commerce Park, Twinsburg OH 44087-2371
  • Source
    USFDA
  • 제조사 주소
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087
  • 제조사 모회사 (2017)
  • Source
    USFDA