{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "123275", "product_res_number": "Z-0491-2014", "event_date_initiated": "2013-08-29", "event_date_posted": "2014-01-03", "recall_status": "Terminated", "event_date_terminated": "2015-11-18", "res_event_number": "66744", "product_code": "IZL", "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.", "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.", "firm_fei_number": "1315356", "recalling_firm": "Carestream Health Inc.", "address_1": "150 Verona St", "city": "Rochester", "state": "NY", "postal_code": "14608-1733", "reason_for_recall": "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.", "root_cause_description": "Radiation Control for Health and Safety Act", "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.", "product_quantity": "310 systerms domestically", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K101517", "K934818", "K211473", "K220678", "K932355", "K120062", "K182207", "K921116", "K231577", "K241505", "K803103", "K932353", "K931279", "K040046", "K790392", "K002685", "K070634", "K211423", "K142383", "K173187", "K781276", "K953292", "K201575", "K170607", "K090655", "K781030", "K032280", "K780313", "K033238", "K080701", "K032628", "K802047", "K143494", "K181626", "K930699", "K203667", "K182317", "K161345", "K203782", "K894643", "K100400", "K192936", "K250597", "K162990", "K253185", "K790511", "K910902", "K260085", "K760741", "K931483", "K022337", "K183292", "K072392", "K973833", "K945707", "K944442", "K212940", "K781425", "K100449", "K953404", "K021016", "K213462", "K923359", "K850678", "K141895", "K191813", "K220700", "K242515", "K241996", "K141885", 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