XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS US

Summary

The FDA issued a Class II for XScribe CP Cardiac Stress Testing System, version 6, with below product names an by Baxter Healthcare Corporation. Reason: Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled..

Details

Product Description

XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53; e) XSCRIBE CP KIT WIRELESS, 41000-030-60; f) XSCRIBE CP KIT WIRED, 41000-030-62; g) XSCRIBE CP SW KIT, 41000-030-64

Lot/Code Info: Product Code, UDI/DI Number, Serial Numbers a) 41000-030-50, UDI/DI None, Serial Numbers: 110120039437, 110120039438, 110120039439, 110190044556, 110190044557, 110190044558, 110190044559, 110190044560, 110190044561, 110190044562, 110190044563, 110190044564, 110190044565, 110190044566, 110190044567, 110200045831, 110200045832, 110200045833, 110200045834, 110200045835, 110260052818, 110260052819, 110260052820, 110260052821, 110260052822, 110260052823, 110420061166, 110420061167, 110420061168, 110420061169, 110460064753, 110460064754, 110460064755, 110460064697, 110460064698, 110460064699, 110460064700, 110460064702, 110460064703, 110460064704, 110460064705, 110460064706, 111150077803, 111150077804, 111150077805, 111150077806, 111150077807, 111150077808, 111150077809, 111200081334, 111200081335, 111200081336, 111200081337, 111200081338, 111200081339, 111200081340, 111200081341, 111300088621, 111300088622, 111300088623, 111300088624, 111300088625, 111300088626, 111300088627, 111340091242, 111340091243, 111360092140, 111360092141, 111360092142, 111360092143, 111360092144, 111340091246, 111340091247, 111340091248, 111340091249, 111340091250, 111420097839, 111420097840, 111420097841, 111420097842, 111420097843, 111500103083, 111500103084, 111500103085, 111500103086, 111530104948, 111530104949, 111530104950, 111530104951, 112020106363, 112020106364, 112020106365, 112020106366, 112020106367, 112020106368, 112020106369, 112020106370, 112180115629, 112180115630, 112180115631, 112180115632, 112180115633, 112180115634, 112180115635, 112200117094, 112200117095, 112200117096, 112200117097, 112200117098, 112200117099, 112200117100, 112200117101, 112200117102, 112200117103, 112320128027, 112320128028, 112320128029, 112320128030, 112320128031, 112350130930, 112350130931, 112350130932, 112350130933, 112350130934, 112350130935, 112350130936, 112350130937, 112440138921, 112440138922, 112440138923, 112440138924, 112440138925, 112440138926, 112440138927, 112440138928, 112440138929, 112440138930, 112440138931, 112440138932, 113010147090, 113010147091, 113010147092, 113010147093, 113070153116, 113070153117, 113070153118, 113070153119, 113070153120, 113070153121, 113070153122, 113070153123, 113070153124, 113070153125, 113070153126, 113070153127, 113070153128, 113070153129, 113270168996, 113270168997, 113270168998, 113270168999, 113270169000, 113310172113, 113310172114, 113310172115, 113310172116, 113350174038, 113350174039, 113350174040, 113350174041, 113350174046, 113350174047, 113350174042, 113350174043, 113350174044, 113350174045, 113410177775, 113410177776, 113410177777, 113410177778, 113410177779, 113410177780, 113410177781, 113440180951, 113440180952, 113440180953, 113470184299, 113470184300, 113470184301, 113530189429, 113530189430, 113530189431, 113530189432, 113530189433, 113530189434, 114050192901, 114050192902, 114050192903, 114090196065, 114090196066, 114090196067, 113460182788, 113460182789, 113460182790, 113460182791, 113460182792, 113460182793, 114420232656, 114420232657, 114420232658, 114420232659, 114420232660, 114420232661, 114480237409, 114480237410, 114420232662, 114420232663, 114420232664, 114420232665, 114520240984, 114520240985, 114520240986, 114520240987, 114520240988, 114520240989, 115050243901, 115050243902, 115050243903, 114470236646, 114470236647, 114470236648, 115230258572, 115230258573, 115230258574, 115230258575, 115230258576, 115230258424, 115230258425, 115230258426, 115280263454, 115280263455, 115280263456, 115280263457, 115280263458, 115280263459, 115280264206, 115280264207, 115280264208, 115280264209, 115280264210, 115280264211, 115330268899, 115330268900, 115330268901, 115330268902, 115330268903, 115330268904, 115400275479, 115400275480, 115400275481, 115400275482, 115400275483, 115400275484, 115400275485, 115400275486, 115400275487, 115400275488, 116020287198, 116020287199, 116020287200, 116100335156, 116100335157, 116100335158, 116130382423, 116130382424, 116130382425, 116130382426, 116130382427, 116180422043, 116180422044, 116180422045, 116180422046, 116180422047, 116240477718, 116240477719, 116240477720, 116240477721, 116270497993, 116270497994, 116270497995, 116270497996, 116380527123, 116380527124, 116380527125, 116380527126, 116380527127, 116380527128, 116380527129, 116380527130; b) 41000-030-51, UDI/DI None, Serial Numbers: 110120039425, 110120039426, 110120039427, 110190044568, 110190044569, 110190044570, 110200045836, 110200045837, 110200045838, 110330056675, 110330056676, 110370059009, 110370059010, 110370059011, 110390059824, 110420060941, 110420060942, 110500066898, 110500066899, 110500066900, 111060071714, 111060071715, 111060071716, 111150077462, 111150077463, 111200081342, 111200081343, 111270086404, 111270086405, 111270086406, 111270086407, 111380093553, 111380093554, 111380093555, 111380093556, 111380093557, 111470101214, 111470101215, 111500103087, 111500103088, 111500103089, 112030106627, 112030106628, 112050108028, 112050108029, 112100110764, 112100110765, 112050108026, 112050108027, 112220118711, 112220118712, 112220118713, 112270124286, 112270124287, 112270124288, 112320128032, 112320128033, 112320128034, 112410137135, 112410137136, 112410137137, 112440139667, 112440139668, 112440138933, 112440138934, 112440138935, 112440138936, 112440138937, 112440138938, 113020147730, 113020147731, 113020147732, 113020147733, 113020147734, 113020147735, 113020147736, 113020147737, 113130159216, 113130159217, 113130159218, 113130159219, 113130159220, 113130159221, 113130159222, 113130159223, 113130159224, 113130159225, 113130159226, 113130159227, 113130159228, 113130159229, 113130159230, 113450181907, 113450181908, 113480185307, 113480185308, 113450181644, 113450181645, 113450181646, 113450181647, 113450181648, 113450181649, 113450181650, 113450181651, 113450181652, 113450181653, 114380229638, 114380229639, 114440234317, 114440234325, 114470236649, 114470236650, 114480237351, 114480237352, 114480237353, 114480237354, 114480237349, 114480237350, 115060244042, 115060244043, 115100247551, 115100247552, 115100247553, 115140251901, 115140251902, 115140251903, 115140251904, 115140251905, 115140251906, 115140251907, 115140251908, 115200256104, 115200256105, 115230258565, 115230258566, 115230258567, 115230258568, 115240258971, 115240258972, 115240258973, 115240258974, 115200256100, 115200256101, 115200256102, 115200256103, 116020287201, 116020287202, 116050291262, 116050291263, 116100335159, 116100335160, 116140387942, 116140387943, 116140387944, 116180423551, 116180423552; c) 41000-030-52, UDI/DI None, Serial Numbers: 110120039363, 110120039364, 110230049218, 110230049219, 110230049220, 110230049221, 110280053721, 110280053722, 110280053723, 110280053724, 110280053725, 110330056793, 110330056794, 110370059012, 110370059013, 110370059014, 110410060508, 110410060509, 110410060510, 110410060511, 110440063042, 110440063043, 110440063044, 110440063045, 110460064750, 110460064751, 110460064752, 110460064707, 110460064708, 110460064709, 110460064710, 110460064711, 110460064712, 110460064713, 110460064714, 111060071710, 111060071711, 111060071712, 111060071713, 111200081535, 111200081536, 111200081537, 111230083963, 111230083964, 111230083965, 111330090559, 111330090560, 111330090561, 111330090562, 111330090563, 111330090564, 111330090565, 111450099468, 111450099469, 111450099470, 111450099471, 111450099472, 111450099473, 111450099474, 111450099475, 111460100779, 111460100780, 111460100781, 111490102399, 111490102400, 111490102401, 111460100426, 111460100427, 111460100428, 112020105816, 112020105817, 112020105818, 112020105819, 112020105820, 112020105821, 112130112152, 112130112153, 112130112154, 112130112155, 112130112156, 112130112157, 112280125032, 112280125033, 112280125034, 112280125035, 112280125036, 112280125037, 112250123314, 112250123315, 112250123316, 112250123317, 113100155571, 113100155572, 113130159201, 113130159202, 113130159203, 113130159204, 113130159205, 113130159206, 113130159207, 113130159208, 113130159209, 113130159210, 113130159211, 113130159212, 113130159213, 113130159214, 113130159215, 114020190211, 114020190212, 114020190213, 114020190214, 114020190215, 114020190216, 114020190217, 114180209245, 114180209246, 114020190218, 114020190219, 114180209247, 114180209248, 114180209249, 114180209250, 114180209251, 114180209252, 114250218419, 114460236532, 114460236533, 114460236534, 114460236529, 114460236530, 114460236531, 114460236526, 114460236527, 114460236528, 115260260562, 115260260563, 115260260564, 115360271118, 115360271119, 115360271120, 115440278666, 115440278667, 115440278668, 115500283264, 115500283265, 115500283266, 116050290129, 116050290130, 116050290131, 116050290132, 116110349285, 116110349286, 116110349287, 116110349288, 116110349289, 116200433074, 116200433075, 116230452680, 116230452681, 116230452682, 116280504772, 116280504773, 116280504774; d) 41000-030-53, UDI/DI None, Serial Numbers: 110120039428, 110120039429, 110120039430, 110120039431, 110120039432, 110120039433, 110120039434, 110120039435, 110120039436; e) 41000-030-60, UDI/DI 00817655020051, Serial Numbers: 118060611436, 118060611438, 118060611439, 118080615013, 118080615022, 118180634934, 118080615011, 118180634932, 118180634933, 118180634936, 118060611447, 118080615017, 118080615018, 118080615021, 118080615019, 118080615020, 118180634938, 118180634939, 118180634940, 118160628568, 118160628569, 118160628570, 118180634931, 118180634935, 118160628577, 118160628578, 118160628579, 118160628580, 118160628581, 118160628583, 118160628564, 118160628565, 118160628566, 118160628567, 118160628571, 118160628572, 118160628573, 118160628582, 118160628574, 118160628575, 118160628576, 118340001391, 118340001392, 118340001393, 118340001394, 118340001395, 118340001396, 118340001397, 118340001388, 118340001389, 118340001390, 119110000129, 119110000130, 119110000132, 119110000133, 119110000134, 119110000135, 119110000136, 119110000137, 119130001327, 119130001328, 119130001331, 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117430591980, 117430591981, 117490599622, 117490599623, 117490599624, 117490599625, 117490599627, 117490599628, 117490599630, 117490599619, 117490599620, 117490599621, 117490599626, 117490599629, 117490599631, 117490599632, 117490599633, 117510602851, 117510602852, 117510602853, 117510602854, 117520603151, 117520603152, 117520603153, 117520603154, 118030606983, 118030606984, 118030606985, 118030606986, 118030606987, 118030606988, 118030606989, 118030606990, 118030606991, 118030606992, 118050609193, 118050609194, 118050609195, 118050609196, 118050609199, 118050609200, 118050609201, 118050609202, 118060611433, 118060611429, 118060611430, 118060611431, 118060611432, 118060611434, 118060611435, 118060611437, 118060611440, 118080615016, 118080615015, 118080615014, 118080615012, 118080615010, 118080615009, 118080615008, 118080615007, 118080615006, 118080615005, 118080615004, 118080615003, 118060611448, 118060611446, 118060611445, 118060611444, 118060611443, 118060611442, 118060611441, 41000-030-60, 118180634941, 118180634942, 118340001398, 118340001399, 118340001400, 118340001401, 118340001402, 118340001403, 118340001404, 118340001405, 118340001406, 118340001407, 118340001408, 118340001409, 118340001410, 118340001411, 118340001412, 120180001027, 120180001028, 120180001029, 120180001030, 120180001031, 10081765502005100, 121040002235, 121040002236, 121040002237, 121040002238, 121040002239, 121040002240, 121040002241, 121040002242, 121040002243, 121040002244, 121050001674, 121050001675, 121050001676, 121050001677, 121050001678, 121050001679, 121050001680, 121050001681, 121050001682, 121050001683, 121080000925, 121080000926, 121080000927, 122200001932, 10081765502005100, 123390000815, 123390000816, 123390000817, 123390000818, 123400000181, 123400000182, 123400000183, 123400000184, 123420000969, 123420000970, 123420000971, 123420000972, 123430002087, 123440000214, 123440000215, 123440000216, 123440000217, 123450001456, 123450001457, 123450001458, 123450001459, 123480000269, 123480000270, 123480000271, 123480000272; f) 41000-030-62, UDI/DI 00817655020068, Serial Numbers: 118160628584, 118160628585, 118320000033, 118330000323, 118330000325, 118320000032, 118330000324, 118330000326, 118330000320, 118330000321, 118330000322, 118450000081, 118450000082, 118330000319, 118470000102, 118470000406, 118470000407, 118470000408, 118480000446, 118480000447, 118480000448, 118480000449, 118500001826, 118500001827, 118500001834, 118500001835, 118500001828, 118500001830, 118500001829, 118500001831, 118500001832, 119190000641, 119190000642, 119190000638, 119190000639, 119190000640, 118500001825, 118500001833, 119250001407, 119320001005, 119320001006, 119320001007, 119320001002, 119320001003, 119320001004, 119350002522, 119350002523, 119350002524, 119350002525, 119430001320, 119430001321, 119430001322, 119430001323, 119430001318, 119430001319, 119470002142, 119470002144, 119470002146, 119470002143, 119470002145, 119470002147, 120040000343, 120040000344, 120050001743, 120050001744, 120050001745, 120080000456, 120080000457, 120080000458, 120080000459, 120080000460, 120080000461, 120080000462, 120080000463, 120080000464, 120080000465, 120080000466, 120080000467, 120080000468, 120080000469, 120080000470, 120080000471, 120080000472, 120080000473, 120080000474, 120330000674, 120330000676, 120050001744, 120050001745, 120330000671, 120330000672, 120330000673, 120330000675, 120330000677, 120330000678, 120330000679, 120330000680, 120050001743, 120480000397, 120480000396, 120520000680, 120520000681, 120520000682, 121060001019, 121060001020, 121060001021, 121080000928, 121080000929, 121130001120, 121130001121, 121130001122, 121170000326, 121170000327, 121170000328, 121210002563, 121210002564, 121210002565, 121250000663, 121250000664, 121250000665, 121300001889, 121300001890, 121300001891, 121340000858, 121340000859, 121340000860, 121420001162, 121420001163, 121420001164, 121420001165, 121470000236, 121470000237, 121470000238, 121510001415, 121510001416, 121510001417, 122050001914, 122050001915, 122050001916, 122080000224, 122080000225, 122080000226, 122130000547, 122130000548, 122130000549, 122240001057, 122240001061, 122240001062, 122240001058, 122240001059, 122240001060, 122240001063, 122310000395, 122310000396, 122310000397, 122320000145, 122320000146, 122320000147, 122320000881, 122320000882, 122320000883, 122380000624, 122380000625, 122380000626, 122450001792, 122450001793, 122450001794, 122480001906, 122480001909, 123020001482, 123020001483, 123070001510, 123070001513, 123070001514, 123070001515, 123100001935, 123100001936, 123070001509, 123070001511, 123070001512, 123190000747, 123190000749, 123150002638, 123190000748, 123200000231, 123150002639, 123220001435, 123220001436, 123300001463, 123300001464, 123300000098, 123300000099, 123370000075, 123370000076, 122480001907, 122480001908, 123320000988, 123300001462, 123320000989, 123320000986, 123320000987, 120050001743, 120050001744, 120050001745, 120330000674, 120330000676, 120480000396, 113400177568, 116480540898, 116530547192, 116530547193, 116530547194, 117010549589, 117010549590, 117110556514, 117110556515, 117110556516, 117130560456, 117130560457, 117130560458, 117150562750, 117150562748, 117150562749, 117180567076, 117180567077, 117190568320, 117210570063, 117210570064, 117210570065, 117260575996, 117260575997, 117260575998, 117310581180, 117310581181, 117350584629, 117350584630, 117350584631, 117350584632, 117350584633, 117400589290, 117400589291, 117400589292, 117430592542, 117430592543, 117430592544, 117490599636, 117490599637, 117490599639, 117490599634, 117490599635, 117490599638, 118070612685, 118070612687, 118070612686, 118080614439, 118080614440, 118090617067, 118090617068, 118090617071, 118090617070, 118090617069, 118160628588, 118160628587, 118160628586, 118160628589, 118160628590, 118320000034, 118320000035, 118330000327, 118330000328, 118330000329, 120040000345, 120040000346, 120040000347, 120480000398, 120480000399, 120480000400, 120480000401, 120480000402, 120480000403, 120480000404, 120480000405, 120480000406, 120480000407, 120480000408, 123400000068, 123400000069; g) 41000-030-64, UDI/DI 00817655021423, Serial Numbers: 119490000440, 119500001335, 121350001043, 120070000730, 119490000439, 120070000732, 118380003022, 118380003023, 118470000103, 118470000104, 119500001336, 118380003022, 118380003023, 118470000103, 118470000104, 120070000731, 123150002068, 123150002069, 123150002070, 123160000556, 123150002055, 123200001669, 123150002057, 123150002058, 123200001670, 123200001671, 123150002066, 123150002067, 120070000733, 123150002056, 123150002061, 123150002062, 123150002063, 123150002064, 123150002065, 123150002059, 123150002060, 123160000552, 123160000553, 123160000554, 123160000555, 119500001335, 121350001043, 120070000730, 119490000439, 120070000732, 117320582006, 120070000734, 120070000735, 120070000736, 120070000737, 11847000104, 120070000738, 120070000739, 121350001044, 121350001045

Quantity Affected: 1675 units

Reason for Recall

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-12-08

Company