{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "220240", "product_res_number": "Z-2242-2026", "event_date_initiated": "2026-04-24", "event_date_posted": "2026-05-28", "recall_status": "Open, Classified", "res_event_number": "98938", "product_code": "MHX", "k_numbers": [ "K080251" ], "product_description": "GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", "code_info": "UDI (01)00840682144773(10)v5.0.2R1C1, Serial Number or Sales Order Number: SS924160026SA, SS921080002SA, SS923080001SA, SS923080006SA, SS922460008SA, SS921320004SA, SS921320010SA, SS921320012SA, 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SS922290002SA, SS923220003SA, SS923290008SA, SS924020004SA, SS921040002SA, SS921050002SA, SS921060023SA, SS921060025SA, SS921060020SA, SS921060022SA, SS921060016SA, SS921060017SA, SS921060018SA, SS921060021SA, SS921110004SA, SS921110001SA, SS921240007SA, SS920490011SA, SS924430083SA, SS924050023SA, SS924060001SA, SS922080004SA, SS922080005SA, SS922080006SA, SS923240002SA, SS923520001SA, SS922120004SA, SS922390002SA, SS923400001SA, SS922340008SA, SS922340009SA, SS922340010SA, SS922020001SA, SS923230004SA, SS923230005SA, SS923230006SA, SS923470001SA, SS923470002SA, SS923470003SA, SS923470006SA, SS923470007SA, SS923480001SA, SS924060011SA, SS922240002SA, SS924060012SA, SS924070006SA, SS924070010SA, SS921110005SA, SS921180006SA, SS921420001SA, SS921470002SA, SS921470004SA, SS922250003SA, SS922340004SA, SS922460004SA, SS922460007SA, SS924060008SA, SS924060009SA, SS924060010SA, SS922130001SA, SS921300001SA, SS922410002SA, SS920500009SA, SS920500008SA, SS921240009SA, SS923430002SA, 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SS920490006SA, SS920490009SA, SS924040011SA, SS922460002SA, SS922050005SA, SS921490002SA, SS923080005SA, SS924070001SA, SS924040002SA, SS921470003SA, SS920490004SA, SS920510005SA, SS921210006SA, SS920520003SA, SS920510008SA, SS920490005SA, SS921240008SA, SS924040009SA, SS921150004SA, SS922300002SA, SS921420011SA, SS920490007SA, SS920490008SA, SS921420002SA, SS920490003SA, SS920510012SA, SS920510011SA, SS923250001SA, SS924040007SA, SS922390003SA, SS922420001SA, SS921130002SA, SS921350001SA, SS923110004SA, SS924050018SA, SS924050019SA, SS924050020SA, SS924050021SA, SS924050022SA, SS924050024SA, SS923210002SA, SS923210003SA, SS924050002SA, SS921300004SA, SS922340007SA, SS923400002SA, SS923420001SA, SS924020002SA, SS920510004SA, SS924060002SA, SS921520006SA, SS923080004SA, SS922240001SA, SS923030005SA, SS921460011SA, SS920510002SA, SS924020001SA, SS924020003SA, SS923030001SA, SS921210004SA, SS924150003SA, SS921060027SA, SS921030011SA, SS923170001SA, SS922170001SA, SS922170002SA, SS922170003SA, SS923230024SA, SS920510001SA, SS922310002SA, SS923290001SA, SS922300003SA.", "firm_fei_number": "3001570235", "recalling_firm": "GE Medical Systems Information Technologies Inc", "address_1": "3114 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 of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).", "root_cause_description": "Software design", "action": "GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 4/24/2026 by letter using a traceable means. The notice explained the the safety issue pertaining to the persistent NO COMM or OFF NETWORK condition, and provided instructions for the safe use of the device should either issue arise. \n\"Actions to be taken by Customer/User \nPending corrections from GE HealthCare, you can continue to use your ApexPro CTS with Central Station for telemetry only or combination monitoring unless you observe a persistent (more than a few seconds) NO COMM or OFF NETWORK notification. \nIf you do observe a persistent NO COMM or OFF NETWORK notification, follow the instructions below. \n1. Use alternative bedside patient monitoring to ensure continuous clinical surveillance until the NO COMM or OFF NETWORK condition is resolved by GE HealthCare. NOTE: If you are using combination monitoring, it is recommended to switch ECG monitoring to the bedside monitor. \n2. Immediately notify your Facility s Biomedical Engineering, IT or Service Department and contact GE HealthCare Service. \n3. Verify monitoring is restored at the Central Station(s) and/or bedside monitor(s).\nPlease ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please post this notification by your Central Station(s).\nPlease retain this document for your records.\" \n\"GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction.\" \nFor questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "476 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "k_number": [ "K130849", "K081891", "K082045", "K220308", "K143676", "K150082", "K151860", "K132075", "K190011", "K011000", "K000815", "K022889", "K102040", "K033304", "K040395", "K223498", "K012915", "K251702", "K945385", "K073462", "K160981", "K132533", "K023569", "K173036", "K100939", "K081983", "K923054", "K000854", "K990563", "K010923", "K153275", "K113623", "K050141", "K183387", "K011918", "K222586", "K130584", "K112962", "K192137", "K250453", "K062576", "K912188", "K101619", "K922974", "K082280", "K192972", "K110953", "K182075", "K260579", "K090443", "K122253", "K180482", "K102239", "K062144", "K061675", "K041741", "K023698", "K112803", "K100217", 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"K033365", "K120631", "K913263", "K171801", "K043549", "K181831" ], "registration_number": [ "3021736577", "2032233", "3011120183", "3013557562", "3009156722", "3012238587", "3004035727", "3008716327", "3019545235", "3030516450", "3007048291", "3006979678", "3008729547", "3007481893", "2221819", "3016674095", "3003589956", "1218950", "3020115", "9710602", "3010157426", "3012421607", "3018783526", "3014633893", "1651104", "1219324", "9611031", "3004526608", "9681377", "3010536822", "3016852448", "3012528160", "3010390468", "3008363989", "3015328411", "3009673645", "3016931915", "3003832357", "9610816", "3014541700", "3010611950", "3009973336", "3023272766", "3007836437", "3009607734", "8022257", "3010703925", "2025816", "8030978", "1000484830", "3022123357", "3005783425", "3010698831", "3032109181", "3014579161", "9610105", "3016701404", "3006606827", "3007413079", "3008483389", "1930027", "3004977335", "3009443693", "3013500228", "8030229", "3013679558", "3008058135", "3008642652", "3012104670", "3007305624", "3010882708", "3013896610", "3012359877", "3001570235", "3007734888", "3004832480", "3012972516", "3006087789", "3006147705", "3010552191", "3021559257", "3015181391", "3030597679", "3009077524", "3009715978", "3043479346", "3011353843", "9611252", "3031158", "3021219789", "3007603826", "3009499478", "3004196561", "3005877899", "3003591740", "3017446092", "1316463", "3015997711", "2080783", "3005906887", "3030446844", "3000126629", "1066270", "1000122786", "3016618143", "3009831876", "3005521864", "3008255748", "1054713", "3014263632", "3004415095", "3013314298", "3019388613", "3009490946", "3003263092", "3000162901", "3014848734", "3013501110", "3013596024", "3003971136" ], "fei_number": [ "3021736577", "3011120183", "3013557562", "3009156722", "3012238587", "3004035727", "3008716327", "3019545235", "3030516450", "3007048291", "3006979678", "3008729547", "3007481893", "2221819", "3016674095", "3003589956", "1218950", "3020115", "3002807739", "3010157426", "3012421607", "3018783526", "3014633893", "1219324", "3002806783", "3004526608", "3010830833", "3010536822", "3016852448", "3012528160", "3010390468", "3008363989", "3015328411", "3009673645", "3016931915", "3003832357", "3002808182", "3014541700", "3010611950", "3000215024", "3009973336", "3023272766", "3007836437", "3009607734", "3010703925", "2025816", "1000484830", "3005783425", "3010698831", "3032109181", "3014579161", "3016701404", "3000957797", "3006606827", "3007413079", "3008483389", "1930027", "3004977335", "3003142870", "3009443693", "3013500228", "3013679558", "3008058135", "1000114111", "3008642652", "3012104670", "3007305624", "3010882708", "3013896610", "3012359877", "3001570235", "3007734888", "3004832480", "3012972516", "3006087789", "3006147705", "3002807167", "3021559257", "3015181391", "3030597679", "3009077524", "3009715978", "3043479346", "3011353843", "3003757840", "3021219789", "3007603826", "3009499478", "3002807019", "3004196561", "3005877899", "3003591740", "3002737156", "3017446092", "1316463", "3015997711", "2080783", "3005906887", "1051088", "3030446844", "3000126629", "3002807720", "1000122786", "3016618143", "3009831876", "3005521864", "1000300598", "3015191855", "3008255748", "3004415095", "3014263632", "3019388613", "3009490946", "3003263092", "3000162901", "3014848734", "3013501110", "3013596024", "3003971136", "3003513129" ], "device_name": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }