{ "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": "130971", "product_res_number": "Z-0187-2015", "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 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. \r\n\r\n Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of 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. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/ multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.", "code_info": "22002\t619474D630 22004\t618443DISC1 22007\t814623D630 22010\t251639D630 22012\t704355D630 22013\t956523D630 22017\t845454D630 22018\t618842DISC1 22024\t601354D630 22025\t773282D630 22026\t813558D630 22027\t941LWRNM630 22029\tPRINCE630 22030\t281540D630 22032\t417781D630 22033\t601288D630 22034\t913345D630 22036\t318798D630 22039\t614NCH630 22040\t904321DSC1 22041\t317887D630 22042\t318448D630 22043\tJHDSV630NM 22045\t217544PH630 22046\t301877D630 22047\t601798D630 22048\t716372NM630 22049\t580531NM630 22050\t651DSC630 22052\t205333D630 22053\t618942NM630 22054\t813615D630 22055\t719587D630 22056\t903GSD630 22057\t417533D630 22058\t708684D630 22059\t937SNHC630 22063\t707961D630 22064\t918502DIS1 22065\t804675D630A 22066\t469814NM630 22067\t978354DSV630 22068\t585922NM630 22069\t305596D630A 22070\t956523D630 22072\tPOIN630 22077\t816234D630 22081\t808485NM630 22082\t989227D630 22085\t305596D630B 22087\t801714D630 22088\t815564D630 22091\t702388VNM2 22092\t760778D630 22094\t269945D630 22095\t843347D630 22096\t201418D630 22097\t319364D630B 22098\t207664NM630 22099\t334287NM630 22101\t609978D630 22103\t843797TD630 22105\t319364D630A 22112\tOSC630 22117\t330386D630 22119\t909599D630 22122\t904276DSC1 22123\t270417D630 22124\t901226D630 22125\t208455NM630 22126\t409212NM630 22127\t770751D630 22131\tDMP630A 22132\t936NMD630 22134\t856355D630 22135\tDMP630B 22136\t605322D630 22137\t775STMANM630A 22138\t951303D630 22139\t850862D630 22141\t765447D630 22143\t203384D630 22144\tWH231NM630 22145\t603354NM630 22148\t302430NUC630 22149\t229259D630 22150\t910FHHOKENM630 22151\t479967DSC 22156\t607763DIS630 22163\t262798D630 00107BH3\tDZ1060NM01 22090\tNM22090 22003\t030359NU07 22038\t030029NU05 22080\t030151NU15 22073\tNM22073 22074\tNM22074 22118\tNM22118 22120\tNM22120 22130\tNM22130 22051\t905684D630 22114\t514843AD630 22102\tNM22102 22116\tNM22116 22129\tNM22129 22161\tNM22161 00000000083BH6\tEG1040NM01 22014\tM4216453 22016\tM4476428 22079\tV6414107 22084\tM45052111 22121\tM2148252 22001\tTP0004NU01 22011\tPMAB01NU04 22023\tPC3003NU01 22078\t407431NU01 22089\tHC0863NU02 22108\t870939NU02 22109\t870939NU01 22115\t600791NU01 22140\tHG4437NU04 22147\tHC0038NU01 22107\tH3001NUC01 22005\t083026001113611 22133\t083026200011213 22021\tIE1044NM01 22022\tA5384208 22031\tA5812287 22035\tA5131865 22086\tA5366307 22044\tNT1008 22071\tNT3010 22104\tNT3002 22110\tNT3003 22111\tNT3020 CZC1321LZ6\tNT3001 22037\t0850260134 22093\t0850260125 22009\tNO1035MN06 22083\tRU1136NM01 22106\tZA2029NM01 22075\tH002NU03 22113\tO009NU09 22128\t34363NUC01 22015\t00001NUC11 22028\t00052NUC11 22100\t00271NUC10", "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 updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems. This check is being added to prevent a portion of the system falling onto the patient during a scan due to fasteners being loose that secure the camera to the gantry.", "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": "147", "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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