{ "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": "130973", "product_res_number": "Z-0189-2015", "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": "Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ.\r\n\r\nProduct Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories", "code_info": "Mfg Lot or Serial #\tSystem ID 24013\t702304NM615 24001\t406222LN615 24003\t478272NM 24004\t405456NM615 24006\t806665NM615 24019\t030151NU17 24011\tNM24011 24014\tNM24014 24020\tNM24020 24015\tNM24015 24016\tGON1427120 24002\tHC0541NU03 24009\t387171NU01 24010\tHC3366NU02 24007\t083026241010212 00000000116BH4\t083026040018413 00000000117BH2\t083026020020313 24008\tA5635609 24017\tNM24017  00000000084BH4\tPK1267NM01 24005\tZA2446NM01 24012\tZA1819NM04", "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": "22", "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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