{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "121430", "product_res_number": "Z-0179-2014", "event_date_initiated": "2013-08-29", "event_date_posted": "2013-11-07", "recall_status": "Terminated", "event_date_terminated": "2016-06-28", "res_event_number": "66067", "product_code": "IZL", "k_numbers": [ "K120062" ], "product_description": "DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608\n\nto perform radiographic x-ray examinations on all pediatric and adult patients", "code_info": "Model: DRXR-1 Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware", "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. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure", "root_cause_description": "Software design", "action": "The firm, Carestream Health Inc., sent an \"Urgent: Medical Device Recall\" letter dated August 29, 2013 to its customers. The letter described the product, problem and actions taken. Carestream has developed a software patch that will allow Normal Exposure Mode and Extended Exposure Mode images to be taken in any order and will install the patch in all DRX-Revolution, DRC-Mobile and DRX-Transportable Systems with software version 5.5 or higher and Detector firmware version 69 or higher. No DRX Transportables were affected. Your Carestream service representative will install the patch at your next service call. \n\n If you have questions or concerns, or if you experience an issue prior to our visit, please contact the Carestream Customer Care Center at 1-800-328-2910, 8am through 8pm Eastern Standard Time.", "product_quantity": "190 units", "distribution_pattern": "Nationwide distribution:AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MI, MO, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, and WV.", "openfda": { "k_number": [ "K182639", "K212654", "K182207", "K103597", "K222339", "K240284", "K972204", "K201340", "K222951", "K231577", "K893637", "K072392", "K811082", "K143494", "K221417", "K200637", "K955036", "K001517", "K012663", "K220700", "K082627", "K251710", "K790451", "K092713", "K120062", "K181626", "K790512", "K163063", "K220678", "K191813", "K111912", "K242015", "K790393", "K953404", "K162990", "K250597", "K251443", "K955095", 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