{ "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": "152283", "product_res_number": "Z-1138-2017", "event_date_initiated": "2017-01-12", "event_date_created": "2017-02-03", "recall_status": "Terminated", "event_date_terminated": "2018-06-13", "res_event_number": "76134", "product_code": "IZL", "k_numbers": [ "K120062" ], "product_description": "Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608", "code_info": "Serial Numbers: 101 to 2545 (Worldwide except China), 800101 to 800468 (China only)", "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": "The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.", "root_cause_description": "Device Design", "action": "Carestream Health Inc. sent an URGENT: MEDICAL DEVICE CORRECTION Letter dated December 29, 2016, and response forms were sent to the US customers via Certified Mail-Return Receipt Requested on January 12, and January 13, 2017, informing them of the problem. Customers are instructed to read and complete all information and return the response form within 5 working days to the following e-mail address: postmarketra@carestream.com, or fax the completed form to (585) 454-4493. UMDC Letters and Response Forms to Canadian Customers were sent the week of January 9, 2017, via courier. Field Safety Notice (FSN) Letters for the rest of world are in process. FSN Letters for the EMEA should be sent via courier starting later this week.\n\nUS Carestream Customer Care Center #: 1-800-328-2910 (24/7). Outside of the US, please call your local Service support number.", "product_quantity": "US: 1403 units; Foreign: 1370 units", "distribution_pattern": "Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Dominican Republic, Dubai, Finland, France, Germany, Ghana, India, Iran, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Libya, Malaysia, Maldives, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates and United Kingdom.", "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", 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