Device Recall Altaire

  • Modelo / Serial
    Serial numbers: L001 to L191.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Direct accounts located in AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
  • Descripción del producto
    Altaire, Magnetic Resonance Imaging Device.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Hitachi Medical Systems America Inc, 1995 Summit Commerce Park, Twinsburg OH 44087-2371
  • Source
    USFDA

2 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / 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.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer
  • Modelo / 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.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    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.
  • Manufacturer