{ "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": "211642", "product_res_number": "Z-0811-2025", "event_date_initiated": "2024-11-25", "event_date_posted": "2025-01-07", "recall_status": "Open, Classified", "res_event_number": "95958", "product_code": "IZL", "k_numbers": [ "K103476", "K142383" ], "product_description": "GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: \n1) 5555000-3; \n2) 5555000-4: \n3) A0659MB", "code_info": "1) 5555000-3: UDI/DI 00840682115278, Serial Numbers: 260665XR220, 478757OPT, 512SDERLM1, 904244MP5, 912466AMX2, 954WRMCDP2; UDI/DI none, Serial Numbers: 10523MOB01, 201418DIG1, 210297NC200M1, 229276M200, 240566P1, 316858AMX200P1, 401OPTI3, 410368WP1, 443643WP1, 503251XR200, 512SDMCP1, 518243OPT2, 603356OPTIMA, 609267OPT, 609267OPT3, 661949DP1, 661949DP2, 718630OPTIMAX, 760379DP, 801299SB1, 804417OPTIMA, 812237P1, 813745OPT1, 856355OPT, 904244MP1, 904244MP2, 904276DP200, 918477OPT1, 956365OPT1, 956632OPT2, 956632OPT4, XR1037005WK4; \n\n2) 5555000-4: UDI/DI 00840682115278, Serial Numbers: 405717P200, 408259AP8, 518583OPT1, 773792XR200, 7982XR0277, 801230XRA, 904399MP19, 989907DP1; UDI/DI none, Serial Numbers: 1553XR0081, 316962240P1, 361572XR220C, 812265M200, A51043204, FEB520100; \n\n3) A0659MB: UDI/DI 00840682115278, Serial Numbers: XR2262CO.", "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": "GE HealthCare Service\n800-437-1171", "reason_for_recall": "GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.", "root_cause_description": "Component design/selection", "action": "GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/25/2024 via letter issued using traceable means. The notice explained the issue, safety issue, and requested the following actions be taken by the user: \n\"1. Perform a check of your device prior to each patient exam to look for the following behaviors. If any are observed, DO NOT use the device and call GE HealthCare Service Immediately.\n. Column vertical movement requires increased effort.\n. Column has change in resistance (i.e. movement is not smooth) during vertical movement.\n. Column makes abnormal noises during vertical movement.\n2. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions.\n3. Please retain this document for your records.\n4. Please complete and return the attached acknowledgement form to RECALL.10964@gehealthcare.com\"\nFor questions or concerns regarding this notification, please contact GE HealthCare\nService at 1-800-437-1171 or your local Service Representative. \nOn 02/11/2025, the firm send an updated notice with a corrected GTIN for Optima XR200amx.", "product_quantity": "53 units", "distribution_pattern": "Worldwide", "openfda": { "k_number": [ "K210982", "K121410", "K813128", "K790392", "K932355", "K012379", "K241505", "K923359", "K032628", "K203782", "K182317", "K202353", "K981466", "K022337", "K173602", "K781030", "K243864", "K234108", "K874840", "K173924", "K944442", "K790451", "K211473", "K151038", "K213405", "K141539", "K202350", "K222258", "K020436", "K833226", "K833239", "K932106", "K122697", "K955095", "K955036", "K211423", "K790393", "K111912", "K241996", "K902984", "K232185", "K973712", "K781705", "K090268", "K221417", "K921425", "K260085", "K912400", "K782155", "K182234", "K071015", "K171353", "K111725", "K251223", "K042361", "K170755", "K141895", "K040046", "K253244", "K043002", "K100400", "K912323", "K781590", "K233678", "K213462", "K203658", "K792665", "K212291", "K052721", "K770903", "K173299", "K201124", "K080701", "K222339", "K183388", "K191025", "K970234", "K930049", "K162278", "K030494", "K222353", "K192936", "K902610", "K850678", "K103522", "K221081", "K891142", "K061685", "K170858", "K142492", "K052001", "K811082", "K911841", "K251443", "K142383", "K843192", "K002685", "K161345", "K122298", "K173187", "K163063", "K260236", "K100449", "K781982", "K043062", "K212515", "K092713", "K083048", "K220678", "K891143", "K162687", "K212654", "K781276", "K042866", "K181874", "K780947", "K781676", "K140723", "K182639", "K953404", "K173018", "K041922", "K945043", "K240841", "K250976", "K143537", "K910902", "K041763", "K010304", "K945707", "K875106", "K162990", "K001517", "K924798", "K790512", "K033238", "K790511", "K802047", "K191884", "K862452", "K932353", "K781975", "K931483", "K082627", "K201340", "K170607", "K941363", "K211383", "K222951", "K181626", "K873982", "K221803", "K072392", "K953292", "K141885", "K931200", "K103476", "K063262", "K193535", "K070634", "K250750", "K241980", "K230581", "K780999", "K253058", "K242515", "K930699", "K780313", "K090655", "K212144", "K973833", "K192011", "K171119", "K052897", "K222896", "K231577", "K220700", "K244049", "K883092", "K183292", "K893637", "K810276", "K890306", "K243473", "K240284", "K032280", "K253185", "K803103", "K153059", "K220175", "K021016", "K212940", "K120062", "K251710", "K894643", "K200726", "K012663", "K781976", "K143494", "K932354", "K080945", "K242015", "K972365", "K062472", "K191813", "K760741", "K240009", "K200976", "K182207", "K934818", "K103597", "K210479", "K921116", "K052341", "K212134", "K191451", "K101517", "K150097", "K781425", "K203667", "K201488", "K042368", "K790443", "K931279", "K250597", "K992229", "K201575", "K200637", "K242651", "K060566", "K213568", "K862118", "K790673", "K894021", "K771571", "K972204", "K090322" ], "registration_number": [ "1418960", "3016250464", "3033527770", "3029916061", "9616047", "9610982", "3006551157", "3009717300", "9614430", "3016674851", "3007734888", "3009077524", "3011015597", "1219183", "3010300212", "3021006193", "3023344919", "3033525986", "3009001657", "3031503890", "3004706313", "8030233", "3015502499", "3024891354", "3018077344", "3025442726", "3011416394", "3015276088", "3008284470", "9615439", "3004606964", "3012127758", "3023003446", "3009715136", "1317307", "3006051164", "3012624817", "3013679558", "3014403439", "3010398867", "3017375271", "3005246977", "3013677815", "3012855798", "3000126629", "3008044777", "3032116890", "3018269927", "9613445", "2433615", "3005810333", "3007836437", "1418964", "3001556265", "3008496839", "3014209556", "2126677", "9617251", "3004977335", "3011950073", "3005877899", "1418484", "3001722928", "3009134655", "3003775006", "1225677", "3003768251", "3013779985", "3007065358", "3004063527", "3014809646", "1222777", "3017944270", "3006542593", "3015537309", "3011491794", "3002707445", "3015223550" ], "fei_number": [ "1418960", "3016250464", "3033527770", "3029916061", "3006551157", "3009717300", "3016674851", "3007734888", "3009077524", "3011015597", "1219183", "3010300212", "3021006193", "3023344919", "3033525986", "3009001657", "3001451453", "3031503890", "3002143662", "3004706313", "3015502499", "3024891354", "3018077344", "3025442726", "3011416394", "3015276088", "3008284470", "3004606964", "3012127758", "3023003446", "3009715136", "1317307", "3006051164", "3012624817", "3013679558", "3014403439", "3010398867", "3017375271", "3005246977", "3013677815", "3012855798", "3000126629", "3008044777", "3002808139", "3032116890", "3018269927", "2433615", "3005810333", "3007836437", "1418964", "3001556265", "3008496839", "3014209556", "2126677", "3003377038", "3002495042", "3004977335", "3011950073", "3005877899", "1418484", "3001722928", "3009134655", "3003775006", "3003768251", "3013779985", "3007065358", "3004063527", "3014809646", "3017944270", "1000120772", "3006542593", "3003861317", "3015537309", "3002175190", "3011491794", "3002707445", "3015223550", "3002807605" ], "device_name": "System, X-Ray, Mobile", "medical_specialty_description": "Radiology", "regulation_number": "892.1720", "device_class": "2" } } ] }