{ "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": "130970", "product_res_number": "Z-0186-2015", "event_date_initiated": "2014-10-14", "event_date_posted": "2014-12-16", "recall_status": "Terminated", "event_date_terminated": "2015-02-27", "res_event_number": "69570", "product_code": "KPS", "k_numbers": [ "K022960", "K052434", "K991841" ], "product_description": "Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. \r\n\r\nProduct Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.", "code_info": 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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": "800-437-1171", "reason_for_recall": "GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.", "root_cause_description": "Nonconforming Material/Component", "action": "The firm, GE Healthcare, sent an \"URGENT MEDICAL DEVICE CORRECTION\" letter, GEHC Ref# 40860, dated October 14, 2014 to its consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, actions to be taken and Contact Information. \r\n\r\nFor questions, consignees in the United States, can contact 1-800-437-1171, for other countries they can contact their GE Healthcare Service Representative.", "product_quantity": "255", "distribution_pattern": "Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.", "openfda": { "k_number": [ "K101550", "K201807", "K921008", "K002584", "K940487", "K992731", "K101013", "K924498", "K981352", "K781753", "K210173", "K915470", "K241266", "K161631", "K090811", "K042467", "K013496", "K050366", "K935318", "K161740", "K892358", "K013504", "K180318", "K911078", "K911290", "K894998", "K960948", "K972509", "K992450", "K190900", "K942837", "K011611", "K083649", "K003882", "K010509", "K133657", "K193241", "K962481", "K041022", "K062450", "K221932", "K072567", "K021823", "K210001", "K003434", "K933321", "K141477", "K243186", "K090403", "K922373", "K003849", "K052640", "K033782", "K972686", "K925330", "K940236", "K873775", "K041182", "K130269", "K243538", "K051460", "K022872", "K852239", "K231748", "K040370", "K180514", "K241585", "K240827", "K922426", "K030199", "K171719", 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