{ "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": "130227", "product_res_number": "Z-0010-2015", "event_date_initiated": "2014-09-05", "event_date_posted": "2014-10-02", "recall_status": "Terminated", "event_date_terminated": "2015-02-20", "res_event_number": "69322", "product_code": "JAA", "k_numbers": [ "K081091" ], "product_description": "GE Healthcare Precision 500D, Classical R&F System.\n\nProduct Usage:\nThe Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.", "code_info": "Mfg Lot or Serial #\tSystem 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"firm_fei_number": "2126677", "recalling_firm": "GE Healthcare, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "262-513-4122", "reason_for_recall": "GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems.", "root_cause_description": "Employee error", "action": "Consignees were sent on 9/5/2014 a GE Healthcare \"Urgent Medical Device Letter\" GE Ref:10893, dated September 5, 2014.\nThe letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology & Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions in USA call 800-437-1171, for other countries contact your local GE Healthcare Service Representative.", "product_quantity": "204 (199 US, 5 OUS).", "distribution_pattern": "Worldwide Distribution - US Nationwide - AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI and in the countries CANADA, GERMANY, UNITED KINGDOM.", "openfda": { "k_number": [ "K905111", "K110785", "K904986", "K970608", "K191877", "K081091", "K904012", "K882311", "K813158", "K871119", "K912380", "K212145", "K233945", "K942264", "K182834", "K220871", "K052610", "K801948", "K061028", "K180589", "K082830", "K913886", "K961690", "K961207", "K811094", "K943532", "K827489", "K810716", "K851031", "K843972", "K771096", "K840390", "K880527", "K840364", "K203428", "K914525", "K123097", "K990055", "K843917", "K103038", "K232526", "K253103", "K200965", "K923137", "K973073", "K111292", "K840134", "K893644", 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