Events

Recall of Device Recall DRXRevolution Mobile XRay System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carestream Health Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66744
  • Event Risk Class
    Class 2
  • Event Number
    Z-0491-2014
  • Event Initiated Date
    2013-08-29
  • Event Date Posted
    2014-01-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123275
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, mobile - Product Code IZL
  • 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.
  • Action
    Carestream sent a letter to all affected customers informing them of the issue, how to detect the issue and actions to be taken by Carestream to correct the issue. The actions to be taken by Carestreamn to correct the issue will include the installation of a software patch to mitigate the effects of the observed failure and remove the possibility of a re-exposure in this failure mode. The correction will be implemented within the US to all affected devices at identified customer sites. For further questions call Carestream Customer Care at 1-800-328-2910, 8 am through 8 pm Eastern Standard Time.

Device

Device Recall DRXRevolution Mobile XRay System
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product 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.
  • Manufacturer
    Carestream Health Inc.

Manufacturer

Carestream Health Inc.
  • Manufacturer Address
    Carestream Health Inc., 150 Verona St, Rochester NY 14608-1733
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    USFDA