{ "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": "150467", "product_res_number": "Z-0332-2017", "event_date_initiated": "2016-10-18", "event_date_posted": "2016-11-02", "recall_status": "Terminated", "event_date_terminated": "2017-04-03", "res_event_number": "75477", "product_code": "MHX", "k_numbers": [ "K122146" ], "product_description": "Xhibit Central Station, Model 96102. \n\nIntended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.", "code_info": "Software version 1.1.5, Affected Serial Numbers in the US ************************************* ADDITIONAL FIVE UNITS ADDED:  SLA0216F01796; SLA0216F01808; SLA1215F01638; SLA1215F01645; SLA1215F01652;   SLA0114F00445, SLA0114F00446, SLA0114F00447, SLA0115F00917, SLA0115F00918, SLA0115F00919, SLA0115F00921, SLA0115F00923, SLA0115F00924, SLA0115F00927, SLA0115F00928, SLA0115F00934, SLA0115F00955, SLA0115F00961, SLA0115F00968, SLA0115F00969, SLA0115F00972, SLA0115F00976, SLA0116F01718, SLA0116F01720, SLA0116F01722, SLA0214F00489, SLA0216F01807, SLA0216F01809, SLA0216F01813, SLA0216F01821, SLA0216F01824, SLA0216F01837, SLA0216F01840, SLA0216F01844, SLA0314F00534, SLA0314F00535, SLA0314F00540, SLA0314F00543, SLA0314F00547, SLA0314F00548, SLA0314F00549, SLA0314F00552, SLA0314F00561, SLA0314F00567, SLA0414F00568, SLA0414F00585, SLA0416F01850, SLA0416F01853, SLA0416F01857, SLA0416F01860, SLA0416F01875, SLA0416F01876, SLA0416F01883, SLA0416F01885, SLA0416F01889, SLA0416F01895, SLA0416F01923, SLA0516F01969, SLA0516F01970, SLA0516F01972, SLA0516F01974, SLA0516F01975, SLA0516F01976, SLA0516F01977, SLA0516F01978, SLA0516F01981, SLA0516F01982, SLA0516F01985, SLA0516F01986, SLA0516F01987, SLA0516F01992, SLA0516F02002, SLA0516F02005, SLA0614F00631, SLA0614F00654, SLA0615F01188, SLA0615F01194, SLA0615F01197, SLA0615F01198, SLA0615F01199, SLA0615F01213, SLA0615F01237, SLA0615F01238, SLA0615F01239, SLA0615F01240, SLA0615F01244, SLA0615F01248, SLA0615F01261, SLA0714F00678, SLA0714F00688, SLA0714F00694, SLA0714F00702, SLA0714F00703, SLA0715F01274, SLA0715F01310, SLA0715F01314, SLA0715F01325, SLA0715F01331, SLA0715F01334, SLA0715F01346, SLA0715F01347, SLA0716F02009, SLA0716F02011, SLA0716F02013, SLA0716F02015, SLA0716F02016, SLA0716F02017, SLA0716F02020, SLA0716F02021, SLA0716F02022, SLA0716F02028, SLA0716F02034, SLA0716F02042, SLA0716F02043, SLA0716F02044, SLA0716F02045, SLA0814F00713, SLA0815F01371, SLA0815F01372, SLA0815F01373, SLA0815F01374, SLA0815F01375, SLA0815F01376, SLA0815F01379, SLA0815F01380, SLA0815F01381, SLA0815F01382, SLA0815F01383, SLA0815F01384, SLA0815F01386, SLA0815F01387, SLA0815F01388, SLA0815F01390, SLA0815F01391, SLA0815F01395, SLA0815F01397, SLA0815F01400, SLA0815F01402, SLA0815F01403, SLA0815F01404, SLA0815F01405, SLA0815F01406, SLA0815F01407, SLA0815F01408, SLA0815F01409, SLA0815F01412, SLA0815F01415, SLA0815F01418, SLA0815F01419, SLA0815F01424, SLA0816F02048, SLA0816F02050, SLA0816F02051, SLA0816F02052, SLA0816F02053, SLA0816F02054, SLA0816F02055, SLA0816F02056, SLA0816F02057, SLA0816F02058, SLA0816F02059, SLA0816F02060, SLA0816F02061, SLA0816F02062, SLA0816F02063, SLA0816F02065, SLA0816F02066, SLA0816F02067, SLA0816F02074, SLA0816F02075, SLA0816F02076, SLA0816F02077, SLA0816F02078, SLA0816F02081, SLA0816F02082, SLA0816F02083, SLA0816F02085, SLA0816F02087, SLA0816F02089, SLA0816F02091, SLA0816F02092, SLA0816F02093, SLA0816F02094, SLA0816F02095, SLA0816F02096, SLA0816F02097, SLA0816F02098, SLA0816F02099, SLA0816F02100, SLA0816F02101, SLA0816F02102, SLA0816F02103, SLA0816F02104, SLA0816F02105, SLA0816F02106, SLA0816F02107, SLA0915F01439, SLA0915F01442, SLA0915F01447, SLA0915F01451, SLA0915F01452, SLA0915F01457, SLA0915F01459, SLA0915F01462, SLA0915F01468, SLA0915F01474, SLA0915F01493, SLA0915F01496, SLA0915F01497, SLA0915F01498, SLA0915F01499, SLA0915F01501, SLA0915F01503, SLA0915F01506, SLA0915F01507, SLA0915F01508, SLA0915F01510, SLA0915F01511, SLA0915F01512, SLA0915F01513, SLA0915F01514, SLA0916F02108, SLA0916F02110, SLA0916F02111, SLA0916F02112, SLA0916F02114, SLA0916F02115, SLA0916F02117, SLA0916F02121, SLA0916F02122, SLA0916F02123, SLA0916F02126, SLA0916F02127, SLA0916F02130, SLA0916F02131, SLA0916F02132, SLA0916F02133, SLA0916F02134, SLA0916F02136, SLA0916F02137, SLA0916F02138, SLA0916F02139, SLA0916F02141, SLA0916F02142, SLA0916F02143, SLA0916F02145, SLA0916F02146, SLA0916F02147, SLA0916F02148, SLA0916F02149, SLA0916F02150, SLA0916F02153, SLA0916F02154, SLA0916F02155, SLA0916F02156, SLA0916F02158, SLA0916F02159, SLA0916F02160, SLA0916F02162, SLA0916F02163, SLA0916F02165, SLA0916F02166, SLA1015F01525, SLA1015F01528, SLA1015F01530, SLA1015F01540, SLA1015F01551, SLA1015F01560, SLA1114F00795, SLA1114F00820, SLA1115F01578, SLA1115F01579, SLA1115F01582, SLA1115F01584, SLA1115F01593, SLA1115F01594, SLA1115F01595, SLA1115F01596, SLA1115F01597, SLA1115F01599, SLA1115F01602, SLA1115F01603, SLA1115F01608, SLA1115F01609, SLA1214F00858, SLA1214F00871, SLA1214F00876, SLA1214F00881, SLA1214F00885, SLA1214F00886, and SLA1215F01632.  ***********Affected Serial Numbers OUTSIDE the US **************************  SLA0114F00430, SLA0114F00437, SLA0114F00438, SLA0114F00439, SLA0114F00440, SLA0114F00443, SLA0115F00975, SLA0116F01724, SLA0314F00528, SLA0314F00541, SLA0414F00596, SLA0416F01872, SLA0416F01877, SLA0416F01880, SLA0612F00235, SLA0715F01270, SLA0715F01271, SLA0715F01273, SLA0715F01283, SLA0715F01335, SLA0716F02023, SLA0716F02025, SLA0716F02029, SLA0716F02031, SLA0716F02035, SLA0716F02036, SLA0716F02037, SLA0716F02040, SLA0716F02041, SLA0716F02047, SLA0815F01431, SLA0816F02049, SLA0816F02064, SLA0816F02069, SLA0816F02070, SLA0816F02071, SLA0816F02072, SLA0816F02073, SLA0816F02079, SLA0816F02080, SLA0816F02084, SLA0816F02086, SLA0916F02109, SLA0916F02118, SLA0916F02119, SLA0916F02120, SLA0916F02128, SLA0916F02129, SLA0916F02140, SLA0916F02161, SLA1014F00776, SLA1113F00348, SLA1113F00368, SLA1115F01604, SLA1115F01605, and SLA1213F00389.", "firm_fei_number": "3010157426", "recalling_firm": "Spacelabs Healthcare Inc", "address_1": "35301 SE Center St", "city": "Snoqualmie", "state": "WA", "postal_code": "98065-9216", "additional_info_contact": "Technical Support\n800-522-7025 Ext. 2", "reason_for_recall": "The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.", "root_cause_description": "Software design", "action": "The firm sent the Urgent - Medical Device Correction letter, dated 18 October 2016, via priority service, return receipt requested, to all U.S. customers on 10/18/16. \n\nThe firm will e-mail a customer letter (translated as necessary) to all international subsidiaries and distributors of record on October 25, 2016.\n\nXhibit Central Stations used without Xhibit Telemetry Receivers, are not affected.\n\nCustomers were asked to circulate the letter to all person affected and place a copy with the appropriate monitor user manual until corrections have been implemented. Spacelabs Healthcare will contact affected consignees to schedule a convenient time for Spacelabs to update the affected Xhibit Central Station(s) with a new software version 1.1.6 at no cost.\n\nCustomers with questions can call Technical Support at 1-800-522-7025 and select 2.", "product_quantity": "348 units (292 units in the US and 56 units outside the US)", "distribution_pattern": "Worldwide Distribution -- USA, to AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MI, MN, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, WY, and Puerto Rico; and, to the countries of AUSTRALIA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, MEXICO, NETHERLANDS, PANAMA, SAUDI ARABIA, SWITZERLAND, TAIWAN, and UNITED KINGDOM.", "openfda": { "k_number": [ "K100040", "K063725", "K130711", "K131414", "K250854", "K013199", "K112190", "K151812", "K031320", "K123556", "K132075", "K060223", "K060135", "K221056", "K101449", "K990563", "K120598", "K240320", "K132533", "K153275", "K223531", "K211900", "K170514", "K112803", "K914838", "K070566", "K062324", "K021325", "K173036", "K031376", "K141963", "K933624", "K192972", "K082045", "K993608", "K950436", "K000815", "K043439", "K141156", "K231671", "K152973", "K141015", "K220308", "K100046", "K060039", "K061052", "K213336", "K110953", "K253170", "K101067", "K191249", "K052756", "K143195", "K121367", "K081140", "K131971", "K944495", "K023569", "K050141", "K223574", "K221904", "K061185", "K033492", "K120366", "K171901", "K163459", "K003621", "K100939", "K012016", "K160685", "K024108", "K923054", "K102376", "K221879", "K192137", "K021422", "K131763", "K072346", "K073462", "K012915", "K081983", "K130584", "K033964", "K950536", "K102040", "K221616", "K152407", "K173454", "K202405", "K110015", "K113054", "K151063", "K130849", "K031781", "K252840", "K051658", "K020531", "K945385", "K022834", "K232962", "K151080", "K031849", "K030738", "K191323", "K081891", "K023674", "K990068", "K950264", "K131872", "K122146", "K043549", "K101619", "K093788", "K102422", "K982279", "K191149", "K123048", "K051628", "K250453", "K040955", "K011000", "K091834", "K992273", "K944860", "K093268", "K110622", "K971840", "K173765", "K250179", "K132026", "K022889", "K002478", "K250349", "K980411", "K992674", "K183387", "K030657", "K990476", "K053522", "K922974", "K181314", "K260098", "K922058", "K102004", "K123472", "K001693", "K033957", "K060281", "K123074", "K040395", "K133576", "K153160", "K071073", "K091594", "K053207", "K213234", "K180472", "K213181", "K041235", "K010923", "K030812", "K001268", "K213799", "K003243", "K210906", "K912627", "K040246", "K013311", "K112637", "K051217", "K190011", "K053484", "K033444", "K251508", "K242962", "K002209", "K242562", "K191106", "K231477", "K060221", "K120727", "K033600", "K090702", "K253277", "K001722", "K042904", "K032369", "K040357", "K150329", "K080157", "K141811", "K013624", "K062194", "K911051", "K062271", "K041772", "K000168", "K041607", "K153448", "K061675", "K131929", "K053121", "K030931", "K000517", "K110922", "K153707", "K103646", "K170567", "K151860", "K153702", "K041741", "K003248", "K001664", "K203435", "K201764", "K912188", "K123900", "K012226", "K101521", "K130208", "K942700", "K092369", "K011093", "K201941", "K172510", "K203088", "K061610", "K063690", "K071164", "K152552", "K190008", "K881643", "K102495", "K992929", "K150352", "K014213", "K062576", "K103652", "K180482", "K013427", "K131876", "K182075", "K180017", "K171580", "K981576", "K092449", "K030575", "K043276", "K081793", "K171801", "K973474", "K030313", "K080251", "K030722", "K061379", "K082785", "K033304", "K082583", "K042642", "K921014", "K092970", "K993974", "K982091", "K160951", "K980619", "K021279", "K062144", "K011918", "K001348", "K200859", "K202336", "K101692", "K962424", "K920445", "K070791", "K945134", "K113187", "K182979", "K161517", "K150030", "K062283", "K151027", "K983996", "K922210", "K000882", "K051400", "K113623", "K113653", "K970182", "K033365", "K213363", "K051367", "K113441", "K062098", "K030613", "K082280", "K240312", "K030431", "K121480", "K030038", "K090556", "K000563", "K172226", "K023871", "K131829", "K061993", "K052801", "K231010", "K133222", "K142827", "K170155", "K192514", "K040304", "K122253", "K071426", "K090443", "K131223", "K251702", "K232694", "K120173", "K132662", "K002158", "K031124", "K091395", "K163584", "K945099", "K031760", "K070588", "K100217", "K211619", "K080342", "K023475", "K102562", "K972535", "K033048", "K031403", "K102239", "K073203", "K190939", "K000854", "K250757", "K050762", "K970445", "K030105", "K083271", "K071020", "K222586", "K922668", "K200494", "K072070", "K131032", "K130401", "K080495", "K011540", "K062095", "K033694", "K200015", "K913263", "K041790", "K181831", "K150082", "K142601", "K252589", "K132077", "K073550", "K031481", "K251146", "K083228", "K090172", "K911646", "K083697", "K161531", "K050742", "K134046", "K120616", "K252250", "K191769", "K872476", "K201746", "K213490", "K092027", "K113657", "K230604", "K924575", "K172966", "K020290", "K122439", "K220989", "K083750", "K052707", "K023698", "K060833", "K992595", "K092680", "K160981", "K912835", "K032290", "K143676", "K040458", "K252726", "K062392", "K001433", "K033711", "K041087", "K042656", "K152902", "K161056", "K073280", "K060541", "K120631", "K043551", "K254209", "K223498", "K063315", "K173768", "K022485", "K103134", "K113045", "K221348", "K170876", "K031340", "K171621", "K150975", "K112962", "K093501", "K014261", "K113798" ], "registration_number": [ "3005877899", "3008255748", "3010698831", "3010882708", "3013500228", "1219324", "3010390468", "1066270", "1218950", "3004415095", "3013501110", "3004977335", "3008729547", "3032109181", "3015181391", "3022123357", "3009499478", "3007305624", "3014633893", "3020115", "3012528160", "3016931915", "8022257", "3013896610", "9710602", "8030978", "3013596024", "2032233", "3031158", "3018783526", "3021559257", "2025816", "9610105", "3004832480", "3007734888", "3012104670", "3003591740", "3011353843", "3021219789", "9611252", "3009607734", "3014541700", "3016674095", "3015997711", "3017446092", "3016852448", "3000162901", "3004196561", "2221819", "3001570235", "3008716327", "1930027", "3010536822", "3013557562", "3005783425", "3005521864", "3012972516", "3003589956", "3015328411", "3030446844", "9681377", "3008363989", "1054713", "3009973336", "3014848734", "3009077524", "3009715978", "3007603826", "3019388613", "3023272766", "9610816", "3003971136", "3008483389", "3012238587", "3003832357", "3013679558", "3030597679", "3012421607", "3007481893", "1316463", "1000484830", "3006979678", "8030229", "3006606827", "3010552191", "3007413079", "3009490946", "3010611950", "3006147705", "3007836437", "3008058135", "3010703925", "3009673645", "3016701404", "3013314298", "3007048291", "1000122786", "3021736577", "3030516450", "3043479346", "3012359877", "3016618143", "3014579161", "3014263632", "3006087789", "9611031", "3011120183", "3003263092", "3005906887", "3004035727", "3009156722", "3004526608", "3010157426", "3009443693", "2080783", "1651104", "3008642652", "3019545235", "3000126629", "3009831876" ], "fei_number": [ "3005877899", "3008255748", "3010698831", "3010882708", "3013500228", "1219324", "3010390468", "1218950", "3004415095", "3013501110", "3002807739", "3004977335", "3008729547", "3032109181", "3015181391", "3009499478", "3007305624", "3014633893", "3003142870", "3020115", "3000957797", "3012528160", "3016931915", "3002737156", "3013896610", "3002806783", "3013596024", "3018783526", "3000215024", "3021559257", "2025816", "3004832480", "3007734888", "3012104670", "3003591740", "1051088", "3002807167", "3011353843", "3021219789", "3009607734", "3015191855", "3014541700", "3016674095", "3015997711", "3017446092", "3016852448", "3000162901", "3004196561", "2221819", "3001570235", "3008716327", "1930027", "3010536822", "3013557562", "3005783425", "3005521864", "3012972516", "3003589956", "3015328411", "3030446844", "3008363989", "3009973336", "3014848734", "3009077524", "3009715978", "3007603826", "3019388613", "3023272766", "3002807720", "1000300598", "3003971136", "3008483389", "3012238587", "3003832357", "3013679558", "3030597679", "3012421607", "3007481893", "1316463", "1000484830", "3006979678", "3006606827", "3003513129", "3007413079", "3002808182", "3009490946", "3010611950", "3006147705", "3007836437", "3008058135", "3002807019", "3010703925", "3009673645", "3016701404", "3007048291", "3010830833", "1000122786", "3021736577", "3030516450", "3043479346", "3012359877", "1000114111", "3016618143", "3014579161", "3014263632", "3006087789", "3011120183", "3003263092", "3005906887", "3004035727", "3009156722", "3004526608", "3003757840", "3010157426", "3009443693", "2080783", "3008642652", "3019545235", "3000126629", "3009831876" ], "device_name": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }