{ "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": "2026-10-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "155553", "product_res_number": "Z-2651-2017", "event_date_initiated": "2017-05-25", "event_date_posted": "2017-06-19", "recall_status": "Terminated", "event_date_terminated": "2018-06-13", "res_event_number": "77250", "product_code": "IZL", "k_numbers": [ "K120062" ], "product_description": "DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- \r\nThe DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures", "code_info": "Serial Numbers: Worldwide except China: 101 through 2623; China only: 800101 through 800482", "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": "Customer Care Center \n800-328-2910", "reason_for_recall": "Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.", "root_cause_description": "Process control", "action": "Carestream Health sent the URGENT MEDICAL DEVICE CORRECTION Letters and Response Forms to the US consignees on May 25, 2017, via Certified Mail, Certified Receipt Requested. Letters to foreign accounts were distributed via e-mail or courier about the same time. Customers with questions were instructed to call 1-800-328-2910.", "product_quantity": "Domestic: 1449 units; Foreign: 1416 units", "distribution_pattern": "Worldwide Distribution - US (nationwide) Internationally to Australia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, India, Japan, Israel, Korea, Malaysia, Maldives, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Switzerland, Taipei, Thailand, Turkey, and UAE.", "openfda": { "k_number": [ "K781976", "K953292", "K201575", "K240284", "K972365", "K173299", "K781590", "K040046", "K173018", "K912323", "K182639", "K211473", "K973833", "K150097", "K182317", "K203658", "K253185", "K041763", "K251223", "K140723", "K242515", "K250750", "K220175", "K203782", "K244049", "K201340", "K921116", "K251710", "K171353", "K770903", "K243864", "K912400", "K141539", "K213405", "K041922", "K931200", "K090268", "K931279", "K212654", "K103597", "K080945", "K923359", "K813128", "K201124", "K934818", "K790451", "K173924", "K260085", 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