{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "120273", "product_res_number": "Z-0090-2014", "event_date_initiated": "2013-07-26", "event_date_posted": "2013-10-31", "recall_status": "Terminated", "event_date_terminated": "2016-05-25", "res_event_number": "65805", "product_code": "IZL", "k_numbers": [ "K120062" ], "product_description": "DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608\r\n\r\nCatalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 \r\n\r\nThe device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.", "code_info": "Serial numbers: U.S. - 134,152,173,174,200,205,222,312,349,353,412, Worldwide Serial numbers: 469, 445, 306, 410, 453, 204, 483, 300, 171, 218", "firm_fei_number": "1315356", "recalling_firm": "Carestream Health, Inc.", "address_1": "150 Verona Street", "city": "Rochester", "state": "NY", "postal_code": "14608-1733", "reason_for_recall": "During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use.", "root_cause_description": "Software design", "action": "Carestream sent a Urgent-Medical Device Recall letter dated July 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\r\n\r\nCarestream Health Inc. recently discovered an image artifact issue due to a detector not being recalibrated with the 5.6B software upgrade. As our installation instructions did not require the user to recalibrate during an upgrade, there is a possibility your detector could do the same. When this occurs an image artifact could be evident on images captured in the Extended Exposure mode. These artifacts could potentially contribute to misdiagnosis or the necessity of patient re-exposure.\r\n\r\nWe request that you take a moment to verify that your detector(s) are calibrated. At our next visit, Carestream will also verify that your detector was re-calibrated and, if not, re-calibrate the detector for you. Please note this only affects systems upgraded in the field.\r\n\r\nFor questions or concerns, please contact the Carestream Customer Care Center at 1-800-328-2910, 8 am through 8 pm EST in the US.", "product_quantity": "23 units installed total (11 domestically & 12 internationally)", "distribution_pattern": "Worldwide Distribution - US (nationwide) including the states of New York, Massachusetts, Pennsylvania, Illinois, Texas, California and Louisiana., and the countries of Australia, Canada, Finland, Italy, Switzerland and United Kingdom.", "openfda": { "k_number": [ "K210982", "K121410", "K813128", "K790392", "K932355", "K012379", "K241505", "K923359", "K032628", "K203782", "K182317", "K202353", "K981466", "K022337", "K173602", "K781030", "K243864", "K234108", "K874840", "K173924", "K944442", "K790451", "K211473", "K151038", "K213405", "K141539", "K202350", "K222258", "K020436", "K833226", "K833239", "K932106", "K122697", "K955095", "K955036", "K211423", "K790393", "K111912", 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