{ "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": "119661", "product_res_number": "Z-0132-2014", "event_date_initiated": "2013-06-19", "event_date_posted": "2013-11-01", "recall_status": "Terminated", "event_date_terminated": "2016-05-20", "res_event_number": "65586", "product_code": "IZL", "k_numbers": [ "K120062" ], "product_description": "DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only).\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: All serial numbers manufactured since inception in June 21, 2012 until June 12, 2013", "firm_fei_number": "1315356", "recalling_firm": "Carestream Health Inc.", "address_1": "150 Verona St", "city": "Rochester", "state": "NY", "postal_code": "14608-1733", "additional_info_contact": "800-328-2910", "reason_for_recall": "Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.", "root_cause_description": "Device Design", "action": "The firm, Carestream Health Inc., sent a \"URGENT: Medical Device Recall\" letter dated June 17, 2013 via courier service to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that there is no opportunity for interference between the End Cover and potential obstructions as the column is descending. Carestream will deploy a field service representative to apply a warning label to the column, and to provide an addendum to the Safety and Regulatory Information manual. Your Carestream service representative will contact you to answer any questions and schedule a visit as soon as possible. \r\n\r\nIf you have any questions or concerns, please contact the Carestream Customer Care Center at 1-800-328-2910 from 8am through 8pm.", "product_quantity": "331 units", "distribution_pattern": "Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, IO, KS, LA, MA, MD, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries of: Australia, Brazil, Canada, Dubai, Germany, Japan, Kuwait, Malaysia, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand.", "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", 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