{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "124190", "product_res_number": "Z-0840-2014", "event_date_initiated": "2013-10-09", "event_date_posted": "2014-01-27", "recall_status": "Terminated", "event_date_terminated": "2014-06-19", "res_event_number": "66917", "product_code": "JAK", "k_numbers": [ "K082816", "K123596" ], "product_description": "GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. \n\nIntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.", "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": "Call Center\n800-437-1171", "reason_for_recall": "There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient's images and another patient's name in the footer. This is also an issue when within Manual Film Composer, if a color image is selected for printing, another patient's black and white image appears in the preview screen", "root_cause_description": "Software design", "action": "Consignees were sent on 10/9/2013 a GE Healthcare \"Urgent Medical Device Correction\" letter dated October 9, 2013. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Directors and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact your local GE Healthcare Service Representative or the GE Healthcare Call Center : US or Canada : 800-437-1171 and Other countries: 262-896-2890).", "product_quantity": "272 (29 US; 243 OUS)", "distribution_pattern": "Worldwide Distribution-USA (nationwide) including the states of AL, CO, FL, IN, KS, KY, MN, NC, OH, TX, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BULGARIA, CANADA, CHINA, ABIDJAN COTEDIVOIRE EGYPT, FRANCE, GERMANY, GREAT BRITAIN, INDIA, IRAQ, ITALY, JAPAN, KENYA, LATVIA, LEBANON, MALAYSIA, MARTINIQUE,MOROCCO, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, PORTUGAL ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and VIETNAM.", "openfda": { "k_number": [ "K022354", "K960985", "K213713", "K932848", "K961464", "K882581", "K201836", "K253596", "K850027", 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