FDAFDA · Alimentos y medicamentos·N.º oficial Z-0491-2014
Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
Publicado el 15 de enero de 2014 · Inicio del retiro: 29 de agosto de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Carestream Health Inc.
- Distribuidor
- Nationwide
- Lote
- DRX Revolution Mobile X-Ray Systems manufactured from June 2012 through October 2013: Serial Numbers DRXR00690, 111, 114, 119, 121, 122, 123, 125, 126, 134, 142, 143, 151, 152, 153, 154, 155, 161, 162, 163, 164, 165, 166, 167, 168, 169, 173, 174, 176, 177, 178, 180, 181, 182, 183, 188, 189, 190, 191, 192, 196, 197, 198, 199, 201, 202, 203, 205, 206, 207, 208, 209, 211, 221, 222, 223, 224, 225, 226, 227, 228, 229, 230, 231, 232, 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249, 254, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 275, 276, 279, 280, 281, 282, 283, 284, 285, 286, 305, 312, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 330, 331, 332, 333, 334, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 353, 355, 357, 358, 359, 360, 361, 362, 363, 364, 365, 372, 373, 375, 376, 379, 380, 381, 382, 383, 384, 385, 386, 388, 394, 395, 396, 397, 398, 399, 400, 401, 403, 405, 412, 413, 414, 415, 417, 420, 421, 423, 431, 432, 433, 434, 435, 441, 442, 443, 444, 451, 452, 454, 455, 456, 457, 458, 459, 460, 461, 464, 466, 467, 487, 488, 489, 490, 495, 506, 510, 511, 512, 514, 515, 516, 517, 518, 519, 520, 521, 522, 523, 524, 530, 538, 541, 542, 543, 544, 545, 546, 547, 548, 549, 555, 557, 560, 561, 562, 563, 564, 581, 583, 584, 590, 591, 592, 593, 594, 595, 596, 597, 598, 599, 601, 602, 603, 609, 610, 611, 612, 613, 614, 616, 619, 620, 621, 622, 626, 627, 628, 629, 631, 632, 633, 634, 635, 636, 637, 639, 644, 645, 649, 650, 651, 656, 657, 658, 659, 660, 661, 663, 664, 665, 676, 677, 682, 685, 686, 687, 688, 689, 691, 692, 694, 696, 697, 698, 699, 700, 702, 703, 704, 705, 706, 707, 718, 723, 724.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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