{ "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": "73331", "product_res_number": "Z-0213-2009", "event_date_initiated": "2008-07-16", "event_date_posted": "2008-11-05", "recall_status": "Terminated", "event_date_terminated": "2015-11-24", "res_event_number": "49440", "product_code": "MSX", "k_numbers": [ "K061994" ], "product_description": "GE Healthcare, Mobile Care Server used in conjunction with Web Viewer, Pocket Viewer, and Cellular Viewer WIT with L-WEB05 software.\n\nGE Healthcare 8200 West Tower Avenue, Milwaukee, WI 53223\n\nMobile Care Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda network or Unity Network and Web Viewer clients.\n\nWeb Viewer can be used for viewing or otherwise processing information from several bedside monitors or other networked devices.\n\nPocket Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other network devices.\n\nCellular Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices.", "code_info": "serial numbers: 5221922, 5221925, 5221927, 5221929, 5221930, 6104032, 6104033, 6131575, 6172651, 6173193, 6241778, 6334201, 6334204, 6393453, CB8717D5D6, CZC53003BG, CZC5391VGC, CZC5460C7C, CZC5460C7D, CZC5460C7G, CZC5460C7L, CZC5462BTV, CZC5462BV0, CZC5462BV1, CZC5462HW2, CZC5462HW3, CZC5472F8K, CZC5472F8M, CZC5492LJT, CZC5492LKJ, CZC5492LKN, CZC5492LLF, CZC5492LLK, CZC5510Y68, CZC5510Y6C, CZC5510Y6F, CZC5510Y6K, CZC5521M4L, CZC5521M4N, CZC603076D, CZC603076H, CZC603076K, CZC603076P, CZC603076S, CZC6030772, CZC61030G7, CZC61030H1, CZC6103GG, CZC6130L2Q, CZC6130L32, CZC6130L39, CZC61544V7, CZC61544VS, CZC61544VX, CZC6181MT3, 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GB8627CX29, GB8627CX2M, GB8627CX2W, GB8627CX31, GB8717D5D0, GB8717D5D1, GB8717D5D2, GB8717D5D3, GB8717D5D4, GB8717D5D5, GB8717D5D7, GB8717D5D8, GB8717D5D9, GB8717D5DA, GB8717D5DB, GB8717D5WS, GB8717D5WV, GB8717D5WX, GB8717D5WY, GB8717D5X1, GB8717D5X3, GB8717D5X4, GB8717D5X5, GB8717D5X7, GB8717D5X8, GB8717D5X9, GB8717D5XA, GB8717D5XB, GB8747301C, GB8747301D, GB8747301H, GB8747301K, GB8747301L, GB8747301N, GB8747301T, GB8747301X, GB8747301Y, GB87473028, GB8747302A, GB8747302J, GB8747302K, GB8747302M, GB8747302N, GB87473030, GB87473031, GB87473034, GB8747303C, GB8747303D, GB8747303J, GB8747303K, GB8747303T, GB8747303Y, GB87473043, GB87473047, GB8747304A, GB8747304E, GB8747304K, GB8813FKF9, GB8813FKFH, GB8813FKFM, GB8813FKFS, GB8813FKH3, GB8813FKH7, GB8813FKHO, GB8813FKHW, GB8813FKJ2, GB8813FKJA, GB8813FKJE, GB8813FKJK, GB8813FKJP, GB8820NIK2", "recalling_firm": "GE Healthcare", "address_1": "Kuortaaneenkatu 2 2 kuortaaneenkatu", "city": "Helsinki", "country": "Finland", "reason_for_recall": "Issue 1 -Possible failure of CIC Pro audible alarms: Requests for telemetry defaults from Mobile Care Server could cause excessive CIC Pro memory consumption. This excessive memory consumption may lead to potential loss of audio at the CIC or a system reset or reboot. Issue 2 - Mobile Care software/Mobile Viewers don not recognize ApexPro FH Telemetry transmitter: Mobile Care server does not ac", "root_cause_description": "Software design", "action": "Consignees contacted via a GE Healthcare Urgent Medical device Correction letter dated 8/26/08 and supplemental instruction for installation of software\" Mobile care server with software, L-WEB05 and iCentral with software, L-NET05 supplemental Instruction for installation\". The letter was addressed to Healthcare Administrator/Risk manger, chief of Nursing and director of Biomedical engineering / IT. The letter also described the problem, affected Products,and Short Term Recommendations .", "product_quantity": "292", "distribution_pattern": "Worldwide Distribution --- USA including states of CALIFORNIA, IOWA, INDIANA, VERMONT, and WASHINGTON and countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CROATIA, CYPRUS, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, and UNITED KINGDOM.", "openfda": { "k_number": [ "K112282", "K962473", "K032346", "K171322", "K061428", "K193391", "K973640", "K253654", "K222550", "K033281", "K071047", "K012531", "K102974", "K040945", "K052975", "K020661", "K061994", "K000647", "K180430", "K103634", "K992848", "K091176", "K013387", "K223567", "K150632", "K020524", "K143057", "K242842", "K992749", "K001972", "K203579", "K100376", "K974101", "K121712", "K211949", "K071391", "K243270", "K102757", "K112047", "K211046", "K973318", "K972880", "K213863", "K241397", "K011999", "K153156", "K182543", "K033078", "K242750", "K042771", "K121885", "K242728", "K052972", "K061932", "K051283", "K012171", "K261367", "K030615", "K070421", "K042845", "K140852", "K990378", "K180566", "K142935", "K012005", "K971868", "K130339", "K231506", "K062278", "K111215", "K202497", "K190073", "K982342", "K233418", "K052854", "K161164", "K151006", "K151672", "K210160", "K193043", "K111296", "K093925", "K974567", "K183238", "K023497", "K212622", "K013156", "K070204", "K191272", "K080192", "K971569", "K022507", "K973527", "K162607", "K210133", "K220058", "K130707", "K121865", "K233834", "K032582", "K994430", "K971683", "K173203", "K193421", "K232548", "K060254", "K141756", "K003998", "K160862", "K192952", "K020018", "K013246", "K010912", "K182637", "K051634", "K132036", "K110521", "K112650" ], "registration_number": [ "", "3008058135", "3010703925", "8020045", "1831750", "9681377", "9611500", "3009673645", "3016701404", "3004906872", "9680215", "3001104093", "9610105", "1000122786", "3010698831", "3009973336", "3013500228", "3008855170", "3018188848", "3012359877", "3016618143", "3009077524", "3011353843", "3016595211", "3007603826", "3011696573", "9611252", "1218950", "3019388613", "3014541700", "3008952681", "3013501110", "9610816", "3006240053", "3011166598", "3004091281", "3008729547", "3006104191", "3009595635", "3014856521", "3003971136", "3003263092", "3016852448", "3038761440", "3013783488", "3044754336", "3027510187", "2221819", "3009499478", "2183613", "3001570235", "3009156722", "3015437214", "3007481893", "3016670256", "1316463", "3004526608", "3012528160", "3010157426", "3005783425", "3009443693", "2080783", "1651104", "3007413079", "3013546957", "3013896610", "3015529350", "3013596024", "2032233", "3015173634", "3015134004", "3000126629", "3000976525", "3009831876" ], "fei_number": [ "", "3008058135", "3010703925", "1831750", "3009673645", "3016701404", "3004906872", "3001104093", "1000122786", "3010698831", "3009973336", "3013500228", "3008855170", "3018188848", "3012359877", "3002807167", "3016618143", "3009077524", "3011353843", "3016595211", "3007603826", "3011696573", "3023530182", "1218950", "3019388613", "3014541700", "3006254866", "6736", "3008952681", "3013501110", "3006240053", "3011166598", "3002807720", "1000300598", "3006104191", "3008729547", "3009595635", "3014856521", "3003971136", "3003263092", "3016852448", "3038761440", "3013783488", "3044754336", "3027510187", "2221819", "3009499478", "2183613", "3001570235", "3009156722", "3015437214", "3003142870", "3007481893", "3016670256", "1316463", "3004526608", "3012528160", "3010157426", "3005783425", "3009443693", "2080783", "3002737156", "3007413079", "3013546957", "3013896610", "3015529350", "3002806783", "3013596024", "3015173634", "3015134004", "3001084824", "3000126629", "3000976525", "3009831876" ], "device_name": "System, Network And Communication, Physiological Monitors", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2300", "device_class": "2" } } ] }