{ "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": "142057", "product_res_number": "Z-0413-2016", "event_date_initiated": "2015-11-13", "event_date_created": "2015-12-12", "recall_status": "Terminated", "event_date_terminated": "2016-09-07", "res_event_number": "72740", "product_code": "IZI", "k_numbers": [ "K122457" ], "product_description": "GE Healthcare Optima CL323i \n\nProduct Usage:\nThe angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.", "code_info": "Mfg Lot or Serial #\tSystem ID 00000085795HL3\t812265CL1 00000086408HL2\t313343IN1 00000087377HL8\t361888CRC 00000089316HL4\t201541LAB1 00000091432HL5\t615396CV1 00000092611HL3\t910671CL323A 00000095315HL8\t910671CL323B 00000096904HL8\t337494CATH1 00000097546HL6\t631654INNOVA 00000097777HL7\t937592OPT 00000098434HL4\t504568INNOVA41 00000098435HL1\t702616RDL31 00000098828HL7\t843339INNOVA2 00000098977HL2\t202269INNOVA 00000099837HL7\t520417OPT3100 00000101009HL9\t308865KR31 00000101825HL8\t216778LABC 00000112807HL3\t517353CATH 00000115275HL0\t407CCE323 00000116573HL7\t509837SSCL1 00000117808HL6\tGON4173729 00000118032HL2\t812284IN31 00000118368HL0\t318330INNOVA1 00000118712HL9\t361788CL323 00000118714HL5\t806358INNOVA 00000119286HL3\t912384CL 00000119585HL8\tGON4263188 00000120996HL4\tGON4263188 00000121694HL4\t229890CL 00000121719HL9\t520GVHCATH 00000124905HL1\t217443PUSAM323 00000124965HL5\t941483CL1 00000126533HL9\t702880CATH1 00000127011HL5\t318704CATH2 00000110028HL8\tDZ1605VA01 00000108050HL6\t082416090051 00000112754HL7\t082416230024 00000113435HL2\tGON4217188 00000113700HL9\t082416010027 00000113963HL3\t082416090050 00000113977HL3\t082416090047 00000116179HL3\t082416090058 00000116903HL6\t082416100086 00000117226HL1\t082416090053 00000117334HL3\t082416120042 00000117414HL3\tGON4229674 00000117572HL8\tGON4242594 00000119287HL1\t082416090062 00000119871HL2\t082416210033 00000120419HL7\t082416190023 00000120578HL0\t082416190021 00000120736HL4\t082416090059 00000120847HL9\t082416090064 00000120867HL7\t082416100085 00000120982HL4\t082416060016 00000121662HL1\t082416090067 00000122668HL7\t082416140017 00000122850HL1\t082416250010 00000123076HL2\t082416180016 00000123319HL6\t082416310033 00000123501HL9\t082416050013 00000123712HL2\t082416200021 00000124692HL5\t082416190022 00000125706HL2\t082416100095 00000125713HL8\t082416190024 00000125813HL6\t082416030027 00000125876HL3\t082416030028 00000125896HL1\t082416110023 00000126170HL0\t082416070041 00000126248HL4\t082416010028 00000126340HL9\t082416200020 00000126419HL1\t082416100096 00000126437HL3\t082416100093 00000126690HL7\t082416090069 00000126899HL4\t082416240010 00000127446HL3\t082416090071 00000127737HL5\tGON4336456 00000127862HL1\t082416290009 00000128225HL0\t082416250011 00000128502HL2\t082416210035 00000128654HL1\t082416070045 00000128767HL1\t082416160051 00000128873HL7\t082416070044 00000128977HL6\t082416020018 00000129200HL2\t082416030030 00000129201HL0\t082416110027 00000127175HL8\tGON4272817 00000121740HL5\tGE1161VA01 00000124022HL5\t083016843923015 00000122051HL6\t0835160056 00000126571HL9\tA5185810 00000100200HL5\tLB1064VA02 00000121474HL1\tLB1001VA01 00000108264HL3\tMQ1008VA02 00000114646HL3\tMA1541VA01 00000115595HL1\tMA1528VA01 00000115655HL3\tMA1422VA01 00000114362HL7\tPL3243VA01 00000116222HL1\tRO1180VA03 00000101672HL4\tRU3412VA02 00000105449HL3\tRU3412VA02 00000117581HL9\tRU8999VA01 00000102617HL8\tGPX25909 00000114902HL0\tXV114950HL9 00000107206HL5\t71006VAS01 00000114949HL1\t35054VAS01 00000121381HL8\t65020VAS01 00000101147HL7\tUZ1027VA01", "firm_fei_number": "2126677", "recalling_firm": "GE Medical Systems, 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 Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems .", "root_cause_description": "Nonconforming Material/Component", "action": "GE Healthcare sent an \"Urgent Medical Device Correction\" letter GEHC Ref#12237 dated November 13, 2015 to customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "108", "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of: AR, AZ, DC, FL, GA, IL, IN, LA, MI, NC, NE, NJ, NV, NY, OH, SC, TN, TX, WA. and the countries of Algeria, Bangladesh, Bosnia and Herzegovina, Brazil, China, Dominican Republic, Ethiopia, Georgia, Germany, India, Indonesia, Italy, Lebanon\nMartinique , Morocco, Poland, Republic of Moldova, Russia, Spain\nThailand, Trinidad, Turkey, and Uzbekistan.", "openfda": { "k_number": [ "K972136", "K130003", "K850455", "K915199", "K955519", "K875376", "K945400", "K875374", "K897115", "K875184", "K913685", "K182907", "K955179", "K984545", "K954581", "K991231", "K972655", "K810183", "K812238", "K222240", "K875375", "K880690", "K100371", "K892849", "K935026", "K170239", "K932410", "K910654", "K931184", "K151780", "K933058", "K062360", "K925961", "K180019", "K190772", "K993765", "K945449", 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"892.1600", "device_class": "2" } } ] }