{ "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": "105891", "product_res_number": "Z-0520-2012", "event_date_initiated": "2011-11-11", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2012-06-05", "res_event_number": "60592", "product_code": "MNR", "k_numbers": [ "K042745" ], "product_description": "Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. \n\nLifescreen Apnea is indicated for screening adults for the probability that they suffer from obstructive sleep apnea, mixed apnea or hypopnea, in order to evaluate the necessity for a polysomonographic examination. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.", "code_info": "There is no Serial Numbers for 169 Kits. Serial Numbers for 519 units:  12038, 32288, 32300, 32302, 32327, 32329, 32330, 32389, 32410, 32411, 32415, 32417, 32418, 32470, 32471, 32472, 32473, 32474, 32475, 32476, 32478, 32479, 32480, 32481, 32482, 32483, 32484, 32485, 32486, 32487, 32488, 32532, 32546, 32547, 32548, 32549, 32550, 32551, 32552, 32553, 32554, 32557, 32558, 32561, 32567, 32568, 32569, 32570, 32648, 32649, 32650, 32651, 32652, 32653, 32655, 32656, 32657, 32658, 32659, 32676, 32677, 32678, 32679, 32680, 32681, 32682, 32683, 32684, 32686, 32687, 32712, 32713, 32714, 32715, 32716, 32717, 32718, 32719, 32720, 32721, 32722, 32723, 32726, 32742, 32759, 32790, 32791, 32797, 32798, 32799, 32800, 32801, 32802, 32803, 32804, 32805, 32806, 32814, 32821, 32822, 32823, 32824, 32860, 32861, 32862, 32863, 32864, 32865, 32866, 32867, 32868, 32869, 32870, 32871, 32872, 32873, 32877, 32878, 32880, 32881, 32944, 32945, 32946, 32947, 32948, 32949, 32950, 32951, 32952, 32954, 32955, 32956, 32957, 32958, 32959, 32960, 32961, 32963, 32977, 32979, 32980, 32982, 32983, 32984, 32986, 32987, 32989, 32990, 32991, 32992, 32993, 32994, 32995, 33015, 33017, 33058, 33095, 33096, 33097, 33098, 33099, 33100, 33101, 33102, 33103, 33104, 33105, 33106, 33107, 33108, 33113, 33114, 33115, 33116, 33117, 33118, 33119, 33120, 33121, 33122, 33123, 33124, 33132, 33135, 33158, 33159, 33160, 33161, 33162, 33164, 33165, 33166, 33167, 33184, 33185, 33186, 33188, 33189, 33190, 33200, 33201, 33213, 33219, 33221, 33240, 33241, 33242, 33243, 33244, 33245, 33254, 33255, 33257, 33258, 33259, 33260, 33261, 33262, 33263, 33264, 33265, 33267, 33268, 33269, 33270, 33322, 33323, 33324, 33326, 33327, 33328, 33329, 33330, 33336, 33337, 33338, 33339, 33343, 33347, 33348, 33352, 33355, 33386, 33387, 33388, 33391, 33392, 33393, 33394, 33396, 9310, 9520, 9885, 9933, 9934, IMP-002054, IMP-005010, IMP-005011, IMP-005013, IMP-005025, IMP-005027, IMP-005028, IMP-005029, IMP-005030, IMP-005031, IMP-005035, IMP-005036, IMP-005038, IMP-005039, IMP-005042, IMP-005043, IMP-005045, IMP-005046, IMP-005048, IMP-005049, IMP-005050, IMP-005062, IMP-005063, IMP-005065, IMP-005066, IMP-005068, IMP-005073, IMP-005077, IMP-005078, IMP-005087, IMP-005090, IMP-005091, IMP-005092, IMP-005094, IMP-005102, IMP-005108, IMP-005110, IMP-005111, IMP-005115, IMP-005141, IMP-005147, IMP-005151, IMP-005152, IMP-005160, IMP-005162, IMP-005165, IMP-005176, IMP-005218, IMP-005219, IMP-005237, IMP-005238, IMP-005253, IMP-005254, IMP-005258, LIFE-025878, LIFE-027365, LIFE-027527, LIFE-027528, LIFE-027866, LIFE-028314, LIFE-029149, LIFE-029150, LIFE-029718, LIFE-029719, LIFE-032784, LIFE-033181, LIFE-033791, PATH-000100, PATH-000101, PATH-000102, PATH-000103, PATH-000104, PATH-000105, PATH-000106, PATH-000107, PATH-006004, PATH-006005, PATH-006006, PATH-006007, PATH-006018, PATH-006019, PATH-006020, PATH-006039, PATH-006040, PATH-006041, PATH-006042, PATH-006043, PATH-006044, PATH-006045, PATH-006068, PATH-006069, PATH-006070, PATH-006071, PATH-006072, PATH-006073, PATH-006074, PATH-006075, PATH-006077, PATH-006099, PATH-006101, PATH-006102, PATH-006103, PATH-006104, PATH-006105, PATH-006106, PATH-006108, PATH-006109, PATH-006110, PATH-006112, PATH-006113, PATH-006114, PATH-006115, PATH-006120, PATH-006132, PATH-006158, PATH-006159, PATH-006160, PATH-006161, PATH-006162, PATH-006163, PATH-006164, PATH-006165, PATH-006166, PATH-006175, PATH-006182, PATH-006183, PATH-006184, PATH-006186, PATH-006188, PATH-006190, PATH-006237, PATH-006238, PATH-006239, PATH-006250, PATH-006251, PATH-006252, PATH-006253, PATH-006254, PATH-006255, PATH-006256, PATH-006258, PATH-006259, PATH-006299, PATH-006300, PATH-006301, PATH-006302, PATH-006306, PATH-006309, PATH-006314, PATH-006315, PATH-006316, PATH-006317, PATH-006318, PATH-006319, PATH-006320, PATH-006321, PATH-006322, PATH-006323, PATH-006324, PATH-006325, PATH-006326, PATH-006327, PATH-006328, PATH-006329, PATH-006332, PATH-006333, PATH-006344, PATH-006350, PATH-006351, PATH-006353, PATH-006382, PATH-006407, PATH-006409, PATH-006410, PATH-006447, PATH-006448, PATH-006451, PATH-006452, PATH-006471, PATH-006485, PATH-006486, PATH-006487, PATH-006488, PATH-006489, PATH-006490, PATH-006502, PATH-006505, PATH-006506, PATH-006522, PATH-006523, PATH-006524, PATH-006525, PATH-006526, PATH-006527, PATH-006528, PATH-006531, PATH-006533, PATH-006537, PATH-006538, PATH-006542, PATH-006543, PATH-006544, PATH-006545, PATH-006572, PATH-006573, PATH-006574, PATH-006602, PATH-006603, PATH-006604, PATH-006605, PATH-006606, PATH-006607, PATH-006608, PATH-006609, PATH-006610, PATH-006611, PATH-006612, PATH-006613, PATH-006614, PATH-006615, PATH-006630, PATH-006631, PATH-006632, PATH-006638, PATH-006650, PATH-006651, PATH-006652, PATH-006662, PATH-006663, PATH-006664, PATH-006665, PATH-006666, PATH-006667, PATH-006698, PATH-006712, PATH-006713, PATH-006714, PATH-006715, PATH-006716, PATH-006717, PATH-006735, PATH-006736, PATH-006738, PATH-006739, PATH-006740, PATH-006741, PATH-006742, PATH-006743, PATH-006744, PATH-006774, PATH-006830, PATH-006831, PATH-006853, PATH-006858, PATH-006859, PATH-006860, PATH-006861, PATH-006862, PATH-006872, PATH-006873, PATH-006874, PATH-006877, PATH-006878, PATH-006984.   4 additional serial numbers were added 6/5/12 - PATH-006332, PATH-006333, PATH-006350, and PATH-006351.", "firm_fei_number": "3002807992", "recalling_firm": "Del Mar Reynolds Medical, Ltd.", "address_1": "1-2 Harforde Ct., Foxholes 1-2 Harforde Ct. Foxholes Business Park", "city": "Hertford", "country": "United Kingdom", "reason_for_recall": "When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information\nManagement System, customers can get corruption in the data or a wrong ECG after the first\n32 hours. Both recordings have to be longer than 32 hours for this to happen.", "root_cause_description": "Software design", "action": "Spacelabs Healthcare sent an \"URGENT-MEDICAL DEVICE CORRECTION\" letter dated November 11, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to close Lifescreen every time before loading another recording from the Sentinel database. Spacelabs is in the process of upgrading software and will contact customers to arrange for an update to affected systems. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.", "product_quantity": "total 523 units and 171 kits (34 units and 7 kits in US; 489 units and 164 kits outside US)", "distribution_pattern": "Worldwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, KY, LA, MA, MD, MI, MN, NC, NY, OH, TN, TX, UT, WV, and PUERTO RICO and the countries of AUSTRIA, BELGIUM, CHILE, CHINA, COLOMBIA, COSTA RICA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, KUWAIT, MALTA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, Slovakia, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM", "openfda": { "k_number": [ "K233501", "K990199", "K180775", "K020312", "K030611", "K220028", "K081982", "K111314", "K000396", "K171304", "K182618", "K021138", "K070855", "K112822", "K163665", "K153070", "K002095", "K203839", "K231546", "K231667", "K002135", "K124062", "K220012", "K111194", "K191095", "K962103", "K081861", "K061705", "K024322", "K222331", "K022506", "K984169", "K180001", "K950273", "K080983", "K030379", "K221816", "K971184", "K944524", "K231355", "K131994", "K010739", "K111742", "K210480", "K990565", "K083874", "K955841", "K244027", "K082968", "K020607", "K131932", "K973920", "K151361", "K161579", "K040069", "K061405", "K081037", "K990321", "K131883", "K040194", "K151874", "K253148", "K240285", "K002159", "K071556", "K080375", "K944611", "K964494", "K013905", "K102567", "K982293", "K940015", "K992322", "K070263", "K081176", "K222579", "K000253", "K040576", "K201495", "K041724", "K220095", "K112102", "K092003", "K252383", "K971803", "K122516", "K012437", "K243220", "K210593", "K052573", "K240100", "K222950", "K041904", "K242424", "K043132", "K173974", "K252628", "K250460", "K252497", "K172799", "K983572", "K060708", "K173793", "K243268", "K090484", "K191925", "K183625", "K033402", "K073682", "K073269", "K223573", "K981034", "K181996", "K010156", "K110486", "K250882", "K021845", "K082853", "K090958", "K110064", "K083575", "K061764", "K081485", "K042253", "K223675", "K191031", "K051313", "K200654", "K163696", "K971501", "K042745", "K110705", "K213463", "K022294", "K041662", "K080427", "K260050", "K140861", "K133859", "K200695", "K143272", "K082113", "K940013", "K242290", "K963597", "K071230", "K083620", "K243092", "K112514", "K072201", "K021176", "K203343", "K160499", "K242224", "K080321", "K072014", "K150102", "K061996", "K151433", "K213360", "K070326", "K254042", "K183559", "K042916" ], "registration_number": [ "", "2184161", "3013689228", "1417592", "1529102", "3002806730", "3003616071", "9613619", "3022315836", "3010399798", "3008717264", "3005581270", "3020283264", "3008820594", "3004016520", "3038274470", "3004964738", "3020018", "3038236812", "2011171", "3026753386", "3009001657", "9611295", "3007573469", "3006606827", "2518422", "3012305175", "3010175098", "3007616088", "1314417", "3006125362", "1423640", "3004748541", "9614500", "9617286", "3007583504", "3016939722", "2132556", "3033526676", "3002912391", "3016998644", "3004531588", "3011061417", "1650946", "3000126629", "3024722701", "3018783526", "3033715634", "3036722175", "3006606984", "3007389703", "3008208119", "3018117195", "8044004", "3008253300", "3006258337", "1063925", "3015529350", "3004428458", "3003832357", "3010157426", "3011205710", "3012302888", "3017638059", "3011120183", "3009770872", "3009498109", "3013724298", "3017684630", "9615102", "3002736372", "3010272829", "3011782009", "9612330", "3023272766", "1118193", "3009351773", "3004604967", "3005873568", "3006463573", "3007799743", "3002797442", "3024891505", "3032906215", "3038185755" ], "fei_number": [ "", "3013689228", "3003208775", "1417592", "3002806730", "3003616071", "3022315836", "3002809369", "3010399798", "3002807992", "1000160007", "3008717264", "3005581270", "3020283264", "3008820594", "1000271197", "3004016520", "3038274470", "3004674371", "3002716534", "3004964738", "3020018", "3038236812", "2011171", "3026753386", "1000221051", "3009001657", "3000225562", "2518422", "3006606827", "3012305175", "3010175098", "3007616088", "1314417", "3006125362", "3004748541", "3007583504", "3016939722", "3004631140", "3033526676", "3002912391", "1000115734", "3016998644", "3004531588", "3011061417", "3000126629", "3024722701", "3018783526", "3033715634", "3036722175", "3006606984", "3007389703", "1000139867", "3008208119", "3018117195", "3008253300", "3006258337", "3000215335", "3010666513", "3015529350", "3004428458", "3003832357", "3010157426", "3011205710", "3012302888", "3002459124", "3017638059", "3011120183", "3009770872", "3009498109", "3013724298", "3017684630", "3010272829", "3023272766", "1118193", "3001227743", "3009351773", "3004604967", "3005873568", "3006463573", "3007799743", "3002797442", "3024891505", "3032906215", "3038185755" ], "device_name": "Ventilatory Effort Recorder", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.2375", "device_class": "2" } } ] }