{ "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": "142059", "product_res_number": "Z-0414-2016", "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 IGS 320.\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": "00000116342HL7\tBA4020VA03 00000127265HL7\tXVV1S15019 00000124734HL5\tXV124857HL4 00000121103HL6\tHC1251XR03 00000102618HL6\t083016020038813 00000128170HL8\t083016061894915 00000115935HL9\t083016100119314 00000125802HL9\t083016200031715 00000123471HL5\t083016208011415 00000118232HL8\t083016240028414 00000122806HL3\t083016247131115 00000112586HL3\t083016280008314 00000119769HL8\t083016284903114 00000122805HL5\t083016287138315 00000114746HL1\t083016289336814 00000116996HL0\t083016601010614 00000112287HL8\t083016801002714 00000108901HL0\t083016801024714 00000122417HL9\t083016807113615 00000109262HL6\t083016807511514 00000123932HL6\t083016809698915 00000119571HL8\t083016824740714 00000110467HL8\t083016846514214 00000104227HL4\t083016860037213 00000125616HL3\t083016860528415 00000113585HL4\t083016861004214 00000128059HL3\t083016862769215 00000126960HL4\t083016029472715 00000120518HL5\t083016866085914 00000120528HL5\tGON4260859 00000010594HL3\t083016844488913 00000105944HL3\tGON4144889 00000129362HL0\t0004344218 00000122667HL9\t5512XR0010 00000124068HL8\t5512XR0032 00000124830HL1\t5512XR0033 00000124904HL4\t5512XR0025 00000125415HL0\t5512XR0034 00000129237HL4\tGON4344915 00000115056HL4\tPL3480VA01 00000128693HL9\t1573XR0032 00000121982HL3\t42026VAS01", "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": "45", "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" } } ] }