Hitachi Medical Systems America Inc

28 devices in the database

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Model / Serial
    Serial Numbers: 11743701 to 11743705  11837701 to 11837705  11906701 to 11906705  12006701 to 12006710  12124701 to 12124710  12315701 to 12315705  12427801 to 12427805
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of OH, FL, CA, TX, DE, VA, NY, MO, KS, NJ, MD and ID.
  • Product Description
    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.
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    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.
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
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3 manufacturers with a similar name

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  • Manufacturer Address
    Hitachi Medical Systems America Inc, 1995 Summit Commerce Park, Twinsburg OH 44087-2371
  • Source
    USFDA
  • Manufacturer Address
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087
  • Manufacturer Parent Company (2017)
  • Source
    USFDA