BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0491-2014 · Reported January 15, 2014

    Enforcement

    Recall Number
    Z-0491-2014
    Event ID
    66744
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2014
    Initiation Date
    August 29, 2013
    Classification Date
    January 3, 2014
    Termination Date
    November 18, 2015
    Address
    150 Verona St, Rochester, NY, 14608-1733, United States

    Description

    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.

    Reason

    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.

    Code Info

    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.

    Distribution

    Nationwide

    Quantity

    310 systerms domestically