Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / Q

Summary

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

Details

Product Description

Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX: f) QS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1: g) QS6 AM12Q TTL KIT AHA / QS-6AC-XXAXX: h) QS6 AM12Q TTL KIT AHA / QS-6AC-XXBXX: i) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXAXA: j) QS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS: k) QS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA: l) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA: m) QS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA: n) QS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA: o) QS6 AM12Q TTL KIT AHA XML / QS6-MXTCS: p) QS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB: q) QS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA: r) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX: s) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX: t) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DEAAX: u) QS6 AM12Q TTL KIT Z200 BCRT AHA DICOM / QS-6AC-CFBAB: v) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFBAA: w) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFBAA: x) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFAAA: y) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFAAA: z) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CECAA: aa) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-AFCXA: bb) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFEAA: cc) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFCAA: dd) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-ACAAB: ee) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-DDBAB: ff) QS6 AM12Q TTL KIT Z200 PCRT AHA SVR / QS-6AC-DDBAC: gg) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-CDBXA: hh) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-DDBAA: ii) QS6 AM12Q TTL SYS AHA XML / QS-6AB-BXAXA: jj) QS6 AM12Q TTL SYS BCRT AHA DICOM / QS-6AB-CGAAB: kk) QS6 AM12Q TTL SYS Z200 BCRT AHA / QS-6AA-DEAXX: ll) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AB-CEAAA: mm) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AD-AEAAA: nn) QS6 AM12Q TTL SYS Z200 PCRT AHA / QS-6AD-BCAAX: oo) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-ACAAB: pp) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-DDAAB: qq) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS6-ATTDX: rr) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS-6AA-XCAAA: ss) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MLTCX: tt) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MTTCX: uu) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-CDCAA: vv) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-DDCAA: ww) QS6 AM12Q TTL TMX KIT BCRT AHA XML / QS-6BC-CGAAA: xx) QS6 AM12Q TTL TMX KIT Z200 PCRT IEC XML / QS-6BC-CDCXA: yy) QS6 AM12Q TTL TMX SYS Z200 BCRT AHA DIC / QS-6BB-CFAAB: zz) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BD-ACAAB: aaa) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BA-ACAAB: bbb) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS6-ATTD1: ccc) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACAAA: ddd) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-DDDAA: eee) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACBAA: fff) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MLTC1: ggg) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MTTC1: hhh) QS6 AM12QKIT AHA XML / QS-6CC-XXAXA: iii) QS6 AM12QKIT AHA / QS-6CC-XXBXX: jjj) QS6 AM12QKIT BCRT AHA DICOM / QS-6CC-XGAAB: kkk) QS6 AM12QKIT BCRT IEC / QS-6CC-DGCAX: lll) QS6 AM12QKIT Z200 AHA / QS-6CC-XAAXX: mmm) QS6 AM12QKIT Z200 BCRT IEC / QS-6CC-DFCAX: nnn) QS6 AM12QSYS BCRT IEC XML / QS-6CA-DGCAA: ooo) QS6 AM12QSYS IEC XML / QS-6CB-CXCXA: ppp) QS6 AM12QSYS Z200 BCRT IEC / QS-6CB-DFCAX: qqq) QS6 AM12QSYS Z200 BCRT IEC XML / QS-6CA-DFCAA: rrr) QS6 NOACQMOD KIT NO LDSET XML / QS-6XC-XXXXA: sss) QS6 NOACQMOD KIT NO LDSET / QS-6XC-BXXXX: ttt) QS6 NOACQMOD KIT NO LDSET DICOM / QS-6XC-XXXXB: uuu) QS6 NOACQMOD SYS Z200 BCRT NO LDSET XML / QS-6XA-DFXAA: vvv) QS6 PRO ENHANCED SECURITY / QS6-STTDX: www)

Lot/Code Info: a) QS6-BXXCS, UDI/DI 00732094263176, Serial Numbers: 116350524925, 116490541255; b) QS-6CC-DGCXX, UDI/DI 00732094308716, Serial Numbers: 119050000134; c) QS-6CC-DFCXX, UDI/DI 00732094308723, Serial Numbers: 122290000606, 122230001869, 122230001868, 122150001605, 122150001604, 122090000843, 119310001134, 119240000440, 122430000522, 122430000523, 119050000135; d) QS-6JB-AXAXA, UDI/DI 00732094263206, Serial Numbers: 123170000019; e) QS6-BLXCX, UDI/DI 0081234502761721, Serial Numbers: 116090330912, 116100344488, 116100344490, 116140389225, 116150394312, 116180422821, 116180422823, 116210442892, 116220445992, 116230451848, 116230455471, 116260496356, 116310521226, 116310521294, 116310521295, 116340523119, 116370526978, 116400530719, 116500543975, 116520546015, 117090555819, 117120557453, 117240573603, 117240573604, 117240573605, 117240573606, 117250575355, 117250575356, 117310581182, 117320582007, 117330583105, 117330583106, 117420591117, 117480596687, 117510602012, 117520603268, 118020605912, 118040608668, 118050610650, 118180633950, 118180633951, 118250001740, 118210638580, 118360000413, 118360000414, 118360000415, 118400000214, 119090001180, 119170000426, 119200000235, 119250000559, 119350003341, 119350003342, 119400001642, 119400001643, 119390002403, 119450000815, 119470000523, 119470000524, 120190001489, 120340001206, 120370000113, 120390000395, 120450000603, 117380587441, 121040002696, 121320000296, 121400000048, 121420000470; f) QS6-BLXC1, UDI/DI 0081234502760021, Serial Numbers: 116110351990, 116170411313, 116180422820, 116190425267, 116200431781, 116200435830, 116200435832, 116210440257, 116210442845, 116220445031, 116220447262, 116220447261, 116220448956, 116240457509, 116240461442, 116240461206, 116250486048, 116250485976, 116250489753, 116260496350, 116260496357, 116260496358, 116260496359, 116270498882, 116280504766, 116280504767, 116280505422, 116290511314, 116290511315, 116290516779, 116300519942, 116300520698, 116310521231, 116310521175, 116320522055, 116330522666, 116340523645, 116370526300, 116370526302, 116380527090, 116370526980, 116390528637, 116380528395, 116390529243, 116390529244, 116390529289, 116390529290, 116390529245, 116390529246, 116400530260, 116430534181, 116440534647, 116440535722, 116450535995, 116460537454, 116460537582, 116490541890, 116500544101, 116500544003, 116510545088, 116520546283, 116530547307, 116530547308, 116530547309, 116520546501, 116530547394, 117010549346, 117020550273, 117040551450, 117030550903, 117050552567, 117080554660, 117110556288, 117120556595, 117140562002, 117170565229, 117170566105, 117230572559, 117230572529, 117230572792, 117230572972, 117240573048, 117240573453, 117240573579, 117280577601, 117290579316, 117300580356, 117320581836, 117320581837, 117320582120, 117380587062, 117390588108, 117450593979, 117450593976, 117450593977, 117450593978, 117480597797, 117480597798, 117480597583, 117480597584, 117520603269, 117520603562, 118040607784, 118090615610, 118090615611, 118140626430, 118150627079, 118160628175, 118150627075, 118150627074, 118150627073, 118150627072, 118150627071, 118150627070, 118150627069, 118120623174, 118180633959, QS6-BLXC1, 118180634187, 118310001237, 118340000912, 118340000913, 118340000914, 118370000773, 118380001940, 118460001584, 118480000810, 118490000217, 118520000406, 119040000078, 119110000757, 119150000254, 119160000043, 119190000970, 119250000554, 119280001984, 119290000535, 119500001105, 120020000304, 120100001917, 120220001572, 120220001573, 120230001261, 120320000243, 120320000244, 120300000912, 120360001047, 121070000465, 121070001280, 121100002344, 121100002345, 121130001104, 121180000761, 121340000883, 121370002510, 121390000795, 121460001255, 122200001819, 122480002102, 123300001831; g) QS-6AC-XXAXX, UDI/DI 00732094301076, Serial Numbers: 123240000013, 123240000012, 123240000011, 123240000010, 123240000009, 120400002601, 120400002600, 120400002599, 120400002598, 120400002597, 120210000914, 120210000913, 120210000912, 120210000911, 120210000910, 120210000909, 120210000908, 120210000907, 120210000906, 120210000905, 120210000904, 120210000903, 119330001329, 119330001328, 119330001327, 119330001326, 119330001325, 119330001324, 119330001323, 119320001019, 119320001018, 119320001017, 119320001016, 119320001015, 119180001173, 119180001172, 119180001171, 119180001170, 119110000755, 118430000951, 11840000949, 118430000948, 118430000949, 123310000826, 123310000827, 123310000828, 123310000829, 123310000830, 123430000320, 123430000321, 123430000322, 123430000323, 123430000324, 123430000325, 123430000326, 123430000327, 123430000328, 123430000329; h) QS-6AC-XXBXX, UDI/DI 00732094346633, Serial Numbers: 123040001807, 123040001806, 123040001805, 123040001804, 123040001803, 122510000875, 122510000874, 122510000873, 122510000872, 122510000871, 122480001730, 122480001729, 122480001728, 122480001727, 122480001726, 122250001966, 122250001965, 122250001964, 122250001963, 122250001962, 122240000488, 122240000487, 122240000486, 122240000485, 122240000484, 122160000349, 122160000348, 122160000347, 122160000346, 122160000345, 122010000998, 122010000997, 122010000996, 122010000995, 122010000994, 121490000353, 121490000352, 121490000351, 121490000350, 121490000349, 121320000685, 121320000684, 121320000683, 121320000682, 121320000681, 121090000175, 121090000174, 121090000173, 121090000172, 121090000171; i) QS-6AC-XXAXA, UDI/DI 00732094355314, Serial Numbers: 123400000592, 123400000593; j) QS6-AXTDS, UDI/DI 00812345027587, Serial Numbers: 116120372696; k) QS-6AC-AXAAA, UDI/DI 00732094263855, Serial Numbers: 118520000406; l) QS-6AC-CXBXA, UDI/DI 00732094263794, Serial Numbers: 116330522481; m) QS-6AC-DXAXA, UDI/DI 00732094263756, Serial Numbers: 116070309986; n) QS-6AC-XXBXA, UDI/DI 00732094263732, Serial Numbers: 117380586614; o) QS6-MXTCS, UDI/DI 0081234502767921, Serial Numbers: 116150390529, 116210438777, 116530547233, 116530547234, 116530547235; p) QS-6AC-CGAAB, UDI/DI 00732094326604, Serial Numbers: 119470001903; q) QS-6AC-XAAXA, UDI/DI 00732094263749, Serial Numbers: 117280578329; r) QS-6AC-DEAAX, UDI/DI 00732094263787, Serial Numbers: 117120558685; s) QS-6AC-DFAAX, UDI/DI 00732094263763, 117160563895; t) QS-6AC-EEBXX, UDI/DI None, Serial Numbers: 118200636641; u) QS-6AC-CFBAB, UDI/DI 00732094318029, Serial Numbers: 123130002242; v) QS-6AC-CFAAA, UDI/DI 00732094263824, Serial Numbers: 122060000614, 121270000363, 117210570696; w) QS-6AC-CFBAA, UDI/DI 00732094318111, Serial Numbers: 123130000023, 123130000022, 123130000021, 123130000020, 123130000019, 123130000018, 122380000698, 121450000731, 121450000730, 123290000564, 123290000565; x) QS-6AC-DFAAA, UDI/DI 00732094263770, Serial Numbers: 118440001972, 119260000952, 119080001406, 119080001405, 118500002162, 118440001973, 118210638583, 118200636642, 118050610062, 118040608669, 117490599962, 117490599961, 117480597107, 117430591574, 117150562907, 116520546288, 116520546282, 116480540169, 116470539963, 116440534646; y) QS-6AC-DFBAA, UDI/DI 00732094302073, Serial Numbers: 122200000715, 122190000632, 122130001859, 122130001858, 122130001857, 122020001892, 122020000512, 122020000511, 121340000499, 121320001535, 121320000290, 121140001779, 120440000212, 119250000555, 119170000486, 122430000520, 122430000521, 119130000111, 119270000118; z) QS-6AC-AFCXA, UDI/DI 00732094263862, Serial Numbers: 118070613220; aa) QS-6AC-CECAA, UDI/DI 00732094336801, Serial Numbers: 123010001116, 120450001427, 120450001426, 120450001425, 123350000876, 123450001519; bb) QS-6AC-CFCAA, UDI/DI 00732094263817, Serial Numbers: 117290578972; cc) QS-6AC-CFEAA, UDI/DI 00732094263800, Serial Numbers: 117430591575; dd) QS-6AC-ACAAB, UDI/DI 00732094263879, Serial Numbers: 123280000370, 123280000369, 123280000368, 123280000367, 123280000366, 123280000365, 123200001032, 123200001031, 123200001030, 123200001029, 123200001028, 123200001027, 123030001347, 123030001346, 123030001345, 123030001344, 123030001343, 123030001342, 123030001341, 123030001340, 123030001339, 123030001338, 123030001337, 123030001336, 122460001577, 122460001576, 122460001575, 122460001574, 122460001573, 121410001264, 121410001263, 121410001262, 121410001261, 121410001260, 121410001259, 121410001258, 121410001257, 121410001256, 121410001255, 121370000467, 121370000466, 121370000465, 121370000464, 121370000463, 121240001238, 121240001237, 121170000417, 121170000416, 121170000415, 121170000414, 121170000413, 121170000412, 121170000411, 121110000836, 121110000835, 121110000834, 121110000833, 121110000832, 121110000831, 121110000830, 121110000829, 121110000828, 121110000827, 121110000826, 121110000825, 121110000824, 121050000578, 121050000577, 121050000576, 121050000575, 121050000574, 118460000414, 118460000413, 118460000412, 118460000411, 118460000410, 118460000409, 118170632607, 118170632606, 118100617938, 118100617937, 118090616426, 118090616425, 118090616424, 117460595390, 117460595389, 117460595388, 117460595387, 117460595386, 117460595385, 117380587627, 117380587626, 117050553076, 117050553075, 117050553074, 116500544083, 116500544082, 116500544081, 123250001021, 123250001022, 123250001023, 123250001024, 123250001025, 123250001026, 123370000153, 123370000154, 123370000155, 123370000156; ee) QS-6AC-DDBAB, UDI/DI 00732094312966, Serial Numbers: 119350002685, 119100000503; ff) QS-6AC-DDBAC, UDI/DI 00732094312959, Serial Numbers: 119350002686; gg) QS-6AC-CDBXA, UDI/DI 00732094263831, Serial Numbers: 123190000068, 123110001251, 122090001000, 116470538496, 116470538495, 116470538494, 116470538493, 116470538492, 116470538491, 116340523788, 116340523787, 116340523786, 123400000105, 123450000611; hh) QS-6AC-DDBAA, UDI/DI 00732094312973, Serial Numbers: 119350002087, 119100000502; ii) QS-6AB-BXAXA, UDI/DI 00732094263916, Serial Numbers: 116110349242; jj) QS-6AB-CGAAB, UDI/DI 00732094263893, Serial Numbers: 122240001151, 120390000393, 118070613221; kk) QS-6AA-DEAXX, UDI/DI 00732094263923, Serial Numbers: 116190431279, 116190431277, 116190431275, 116190431273, 116190431271, 116190431269; ll) QS-6AB-CEAAA, UDI/DI 00732094263909, Serial Numbers: 119270000108, 119040000856, 117490600126, 123110000500; mm) QS-6AD-AEAAA, UDI/DI 00732094288940, Serial Numbers: 118490000214, 118490000213, 118490000212, 118490000211, 118270000503, 118270000502, 118270000501; nn) QS-6AD-BCAAX, UDI/DI 00732094263718, Serial Numbers: 116230451701; oo) QS-6AA-ACAAB, UDI/DI 00732094263947, Serial Numbers: 119240000738, 115510284694; pp) QS-6AA-DDAAB, UDI/DI 00732094263930, Serial Numbers: 116150390528; qq) QS6-ATTDX, UDI/DI 0081234502757021, Serial Numbers: 116070306098, 116070307281, 116070311291, 116110360656, 116110360658, 116110360660, 116190428764, 116190431265, 116190431268, 116190431239, 116190431241, 116210440023, 116220447275, 116250485174, 116250485959, 116260491968, 116260491970, 116260491972, 116260491974, 116280504761, 116280504768, 116290516786, 116290516812, 116290516813, 116290516815, 116280506964, 116280506966, 116300519873, 116320522168, 116330523070, 116340523725, 116340523726, 116340523727, 116340523728, 116350524962, 116370526231, 116370526235, 116380527225, 116380528397, 116380528398, 116380528399, 116380528400, 116390529085, 116390529086, 116390529087, 116400530261, 116410531492, 116410531499, 116420532365, 116440535274, 116440535550, 116450536751, 116460537578, 116460537579, 116490541737, 116460537577, 116500542854, 116500542855, 116500543269, 116510545083, 116530546706, 116530547125, 116530546705, 116530547310, 116530547262, 116530547263, 117010549347, 117010549348, 117010549349, 117030551222, 117030551223, 117030551224, 117030551198, 117060553621, 117080554650, 117090555978, 117120556692, 117120556693, 117120556669, 117120556938, 117120556939, 117110556361, 117130560356, 117130559722, 117130559723, 117130559724, 117130559725, 117130560366, 117130560907, 117130560908, 117130560909, 117130559206, 117130559207, 117140562692, 117140561999, 117140562000, 117180567011, 117200568668, 117200568669, 117200569177, 117210570093, 117210570094, 117210570095, 117210570736, 117230572508, 117230572509, 117230572795, 117230572796, 117230572797, 117240573777, 117250575370, 117260576146, 117260576380, 117260576147, 117260576521, 117260576907, 117270577366, 117270577367, 117270577369, 117300580355, 117260576919, 117330582978, 117340583701, 117340583700, 117340583703, 117350584566, 117360584806, 117380586443, 117380586438, 117380586439, 117380586440, 117380587063, 117390588206, 117410590220, 117420591116, 117460595235, 117480597799, 117490599957, 117490599958, 117490599959, 117500601066, 117480597585, 117490599960, 117510602015, 117510602783, 118010604423, 118030607407, 118030607409, 118050609952, 118090615612, 118090616239, 118190635182, 118180633951, 118150626794, 118110620676, 118110620675, 118030607408, 118110620673, 118110620672, 118110620671, 118110620670, 118120622027, 118110620674, 116520545400, 116520545401, 118200637266, 118200637265, 118200637264, 118190635507, 118190635506, 118190635505, 118190636600, 118190636599, 118210638582, 118210638581, 118240001206, 118250002189, 118250002190, 118260000335, 118260000336, 118260000337, 118260000338, 118260000339, 118260000340, 118260000341, 118260000342, 118260000343, 118270000716, 118270000717, 118300001211, 118300001212, 118310000439, 118310000440, 118310001698, 118340000909, 118340000910, 118340000911, 118350000119, 118350000120, 118350000895, 118360000412, 118370000771, 118370000772, 118370001923, 118390000401, 118400000212, 118400000213, 118420000444, 118420000445, 118450000914, 118450000915, 118460002307, 118480000811, 118480000812, 118480000813, 118490000215, 118490000216, 118520000469, 119030000098, 119060000834, 119070000043, 119090001179, 119100000457, 119120000287, 119120001590, 119120001591, 119160000320, 119190000655, 119220000831, 119230002432, 119230002433, 119240000162, 119240000163, 119240000739, 119250000556, 119250000557, 119250000558, 119260000972, 119260000973, 119260000974, 119260000975, 119260000976, 119260000977, 119260001787, 119260001788, 119260001789, 119270000453, 119280000608, 119280000609, 119290000534, 119290000601, 119300000175, 119330000158, 119330000159, 119330000810, 119350002908, 119350002909, 119380001374, 116300519874, 116300519875, 116300519876, 119420001080, 119420001081, 119420001082, 119420001083, 119460000136, 119460000137, 119460000138, 119460001074, 119460001075, 119470000521, 119470000522, 119470001904, 119470001905, 119470001906, 119470001907, 119480000259, 119480000260, 180, 119500001102, 119500001103, 119500001104, 119520000619, 119520000620, 120020001162, 120050000516, 120060000648, 120070001212, 120070001213, 120070001214, 120070001215, 120070001216, 120070001217, 120080002241, 120080002242, 120110001828, 120110001829, 120110001830, 120130000348, 120130000349, 120130001386, 120130001387, 120140001041, 120140001042, 120140001043, 120140002514, 120140002515, 120160001500, 120160001501, 120160001502, 120160001503, 120160001504, 120160001505, 120180001098, 120180001099, 120180001100, 120180001101, 150160001505, 120230002008, 120230002009, 120230002010, 120230002011, 120230002012, 120230002013, 150160001506, 150160001507, 150160001508, 150160001509, 150160001510, 150160001511, 120310001596, 120310001597, 120310001598, 120360001242, 120360001243, 120360001244, 120360001245, 120380000309, 120380000310, 120390000394, 120390001597, 120390001598, 120400001334, 120400001335, 120410000592, 120410001054, 120410001292, 120410001293, 120410001294, 120410001295, 120410001296, 120450000602, 150160001513, 150160001514, 150160001515, 150160001516, 150160001517, 120460000684, 120460000685, 120460000686, 120460002793, 120460002794, 120470000599, 120480000005, 120480000006, 120480000007, 120490001517, 120490001518, 120490001519, 120490001520, 120490001521, 120490001522, 120490001523, 120490001524, 120490003111, 150160001518, 150160001519, 150160001520, 150160001521, 150160001522, 150160001523, 150160001524, 150160001525, 150160001526, 150160001527, 150160001528, 150160001529, 150160001530, 150160001531, 121030000755, 121030000756, 121070000464, 121070002513, 121070002514, 121090001937, 121090001938, 121090001939, 121090001940, 121120000018, 121120000019, 121120000020, 121120000021, 121120000022, EXCNORETURN, 121140000280, 121140000281, 121140000282, 121160001418, 121160001419, 121190000939, 121200000017, 121200000018, 121230000160, 121230000161, 121230002023, 121240000675, 121240000676, 121240000677, 121300001874, 121310001142, 12130001679, 121330001320, 150160001532, 121360001298, 121360001299, 121360001300, 121360001301, 121360001302, 121390002096, 121390002097, 121390002098, 121400000055, 121400001921, 121400001922, 121400001923, 121420000476, 121430000259, 121450000280, 121450001401, 121460001164, 121480000753, 121480000754, 121500000287, 121500000288, 121500000289, 121500000290, 121500000291, 121500000292, 121510001474, 121510001475, 121520000976, 121520000977, 121520000978, 121520000979, 121520000980, 121520000981, 121520001607, 121520001608, 122010001005, 122010001006, 122010001007, 122010001008, 122020000513, 122020001900, 122020001901, 122020001902, 122020001903, 122040000642, 122040000643, 122050001244, 122050001245, 122050001246, 122050001247, 122070001238, 122070001239, 122070001240, 122070001241, 122070001242, 122250000648, 122250000649, 122250000650, 122250000651, 122250000652, 122250000653, 122250000654, 122250000655, 122250000656, 122260000886, 122290001134, 122290001135, 122290001136, 122290001137, 122290001138, 122310001545, 122310001546, 122320000462, 122350000276, 122350000277, 122360000423, 122360000424, 122370000068, 122370000069, 122370000070, 122430000183, 122450000618, 122450000619, 8, 122480002103, 122480002104, 122480002105, 122480002106, 122490000194, 122490000195, 122490000196, 122490000197, 122490000198, 122490000199, 122500001002, 122500001003, 122500001004, 122510000167, 123010000259, 123010000260, 123010000261, 123010000262, 123010000263, 123030001333, 123030001334, 123030001335, 123050001345, 123050001346, 123050001347, 123050001348, 123070000719, 123090001294, 123100001960, 123100001961, 123100001962, 123100001963, 123100001964, 123170000267, 123180000488, 123180000489, 123210000350, 123210000351, 123250000059, 123250000060, 123250000061, 123250000062, 123250000063, 123250000064, 123250001027, 123260000226, 123270000161, 123270001064, 123270001065, 123270001066, 123270001067, 123270001068, 123270001069, 123270001070, 123270001071, 123280000373, 123280000374, 123280000375, 123290000582, 123290000583, 123290000584, 123300001832, 123300001833, 123300001834, 123310001376, 123310001377, 123310001378, 123330000777, 123330000778, 123330000779, 123350000286, 123350000287, 123350000288, 123350000289, 123380001337, 123380001338, 123410000814, 123410000815, 123430001155, 123430001156, 123430001157, 123430001158, 123430001159, 123430001160, 123430001161, 123430001162; rr) QS-6AA-XCAAA, UDI/DI 00732094326710, Serial Numbers: 122120000190, 122100001656, 122090001811, 122090001810, 122020001000, 122020000999, 122020000998, 121520000975, 121160002375, 120170000553, 120170000554, 122300000629; ss) QS6-MLTCX, UDI/DI 0081234502764821, Serial Numbers: 116080321499, 116100346607, 116130375989, 116130375990, 116130379805, 116210439189, 116210438778, 116230453065, 116230453067, 116250485173, 116240477775, 116260493401, 116240459074, 116270501516, 116270498867, 116280505345, 116290517124, 116290519660, 116300520391, 116320522163, 116320522164, 116320522165, 116330522667, 116330523071, 116340523724, 116350524070, 116380527757, 116410531127, 116480540910, 116490541437, 116490541641, 116520545376, 116530547261, 117030551128, 117040552523, 117050552696, 117110556421, 117110556410, 117140561569, 117170564846, 117160563413, 117170566130, 117180566599, 117190568194, 117190568195, 117210569780, 117210569781, 117230572912, 117250574779, 117260576265, 117260576266, 117280577952, 117270577275, 117300580503, 117330583101, 117370586229, 117370585824, 117390587807, 117470596277, 117470596278, 117510602013, 117510602014, 118020605911, 118030607257, 118030607726, 118070613217, 118100617591, 118180634595, 118180634594, 118150627077, 118150627076, 118160628070, 118140625630, 118120622030, 118130624174, 118110620680, 118110620681, 118190636335, 118190635558, 118250001741, 118270000718, 118270000719, 118270000720, 118270000721, 118270000722, 118290000378, 118290000379, 118290000380, 118290001179, 118310000441, 118310001116, 118350000122, 118350000590, 118370000778, 118370000779, 118390000402, 118410000880, 118420000601, 118420000602, 118420000603, 118430000952, 118430000953, 118440001585, 118490000218, 118500000650, 118500002165, 118500002166, 118520000908, 118520000909, 118520000910, 119040000855, 119050000688, 119050000689, 119070000660, 119070000661, 119100001181, 119120000288, 119120001592, 119120001593, 119200000582, 119220000667, 119250000564, 119250000565, 119250000566, 119250000567, 119250000568, 119250000569, 119270000450, 119270000451, 119270000452, 119280000613, 119320000060, 119330000161, 119340000677, 119340000678, 119350002913, 119350002914, 119350002915, 119350002916, 119350002917, 119350002918, 119350002919, 119350003338, 119350003339, 119370000198, 119370000199, 119370000200, 119370000201, 119370001057, 119370001058, 119400001644, 119400001645, 119400001646, 119400001647, 119400001648, 119400001649, 119400001650, 119400001651, 119460001807, 119460001808, 119480000257, 119480000258, 119510000666, 119510001674, 119520000618, 120020001161, 120080000361, 120130000350, 120130000351, 120140001044, 120180000985, 120180000986, 120330000901, 120330000902, 120330000903, 120390000399, 120430001822, 120450001901, 120470000596, 120530000380, 120530000381, 120530000382, 120530000383, 120530000384, 120530000385, 121040002695, 121060000885, 121060000886, 121070000470, 121070000471, 121070000472, 121070000473, 121070001276, 121070001277, 121080000530, 121090001941, 121090001942, 121130001102, 121130001103, 121140000283, 121140000284, 121140000285, 121160002372, 121160002373, 121160002374, 121190000640, 121200000019, 121200000020, 121200000021, 121200000022, 121200001237, 121200001238, 121200001239, 121220000152, 121220000153, 121220000154, 121220000163, 121230000162, 121240001241, 121290001061, 121290001062, 121300001865, 121300001877, 121310001017, 121350000322, 121350000323, 121350000324, 121350001471, 121360001294, 121360001295, 121370000469, 121370001278, 121370001279, 121390000796, 121430000260, 121450000287, 121450001402, 121450001403, 121480001495, 121520000984, 121520001599, 121520001600, 122010000983, 122020001212, 122020001213, 122020001214, 122020001215, 122040000385, 122050001248, 122050001249, 122060002362, 122060002363, 122090001804, 122090001805, 122110000027, 122120002575, 122120002576, 122120002577, 122140000068, 122190001152, 122190001153, 122190001154, 122190001155, 122190001156, 122190001157, 122190001158, 122190001159, 122190001160, 122190001161, 122230000221, 122240001156, 122240001157, 122240001158, 122240001491, 122290001139, 122340000213, 122380000699, 122390000780, 122410001720, 122430001370, 123010001027, 123010001028, 123010001029, 123030000270, 123040001234, 123040001235, 123040001929, 123070000717, 123070000718, 123080000641, 123080000642, 123110001327, 123190001330, 123230001869, 123280000406, 123280001081, 123300001828, 123300001829, 123300001830, 123320000984, 123350000290, 123430001163, 123430001164; tt) QS6-MTTCX, UDI/DI 0081234502766221, Serial Numbers: 116130382738, 116140389728, 116150390531, 116200435411, 116220448959, 116250480265, 116300520110, 116300520111, 116300520112, 116300520113, 116360525386, 116360525794, 116370526230, 116380528390, 116380528391, 116380527756, 116420532146, 116460538198, 116460538356, 116530546826, 116530546811, 116530546820, 116530546821, 116530546822, 116530546823, 116530546824, 116530546825, 117010548789, 117010548790, 117020550495, 117050553051, 117080555509, 117110556504, 117130560261, 117130560971, 117130560972, 117130560973, 117130560974, 117140562016, 117140562066, 117190567380, 117200568648, 117250574073, 117250574074, 117370585092, 117370585113, 117370585090, 117370585091, 117370585093, 117370585094, 117370585110, 117370585111, 117370585112, 117420590606, 117430591572, 117470596276, 117500601524, 117500601525, 117500601526, 117500601527, 118030607881, 117520603557, 117520603558, 117520603559, 117520603560, 117520603561, 118070612283, 118040607881, 118180634593, 118120622400, 118120622028, 118110620684, 118270000723, 118290000381, 118360000418, 118500002168, 119050000693, 119090000899, 119170000012, 119200000994, 119450000817, 120190000899, 120240000419, 120480001167, 121030000256, 121030000257, 121040002691, 121040002692, 121040002693, 121040002694, 121060000878, 121060000879, 121060000880, 121060000881, 121060000882, 121060000883, 121060000884, 121060000919, 121070002432, 121190000641, 121190000642, 121300001282, 121340000509, 121340000510, 121350001470, 121370002509, 121510001478, 121510001479, 121510001480, 121510001481, 122020000732; uu) QS-6AA-CDCAA, UDI/DI 00732094286021, Serial Numbers: 118180633960; vv) QS-6AA-DDCAA, UDI/DI 00817655021355, Serial Numbers: 117140561568; ww) QS-6BC-CGAAA, UDI/DI 00732094263589, Serial Numbers: 116190425280; xx) QS-6BC-CDCXA, UDI/DI 00732094263596, Serial Numbers: 116140389770; yy) QS-6BB-CFAAB, UDI/DI 00732094263626, Serial Numbers: 116170410170; zz) QS6-ATTD1, UDI/DI 0081234502756321, Serial Numbers: 116070311290, 116070311292, 116070311294, 116100332892, 116130382051, 116130376108, 116140389082, 116140388756, 116170410169, 116180416553, 116180416555, 116190431282, 116210444330, 116230450214, 116230450216, 116240477304, 116240477860, 116240477862, 116240477864, 116240477867, 116240477869, 116240477871, 116230455570, 116230455572, 116230455574, 116230455576, 116230455578, 116230455580, 116230455582, 116230455584, 116230455588, 116310520897, 116310520898, 116230455586, 116310520896, 116320521690, 116320521865, 116330522902, 116330522848, 116330522849, 116340523648, 116350524130, 116370526975, 116400529514, 116400529515, 116400529516, 116400529517, 116400529518, 116390529090, 116370526974, 116400529519, 116400529520, 116400529521, 116400529522, 116400529523, 116400529920, 116400529921, 116400530088, 116400530553, 116400530028, 116420531722, 116420532142, 116430534054, 116430534055, 116450536077, 116450536208, 116460537576, 116460538355, 116460537453, 116470539394, 116490542247, 116490542248, 116510544247, 116510545330, 116510545331, 116520546402, 116520546401, 116520546230, 116520546403, 116520546400, 117050553073, 117060553950, 117080555092, 117090555749, 117090555843, 117090555865, 117090555866, 117090555867, 117110556362, 117110556363, 117110556289, 117110556290, 117120556937, 117120557454, 117120557458, 117120557459, 117120557460, 117130560125, 117130560428, 117130560970, 117140562012, 117150562725, 117140562010, 117140562011, 117150562893, 117160564733, 117170565765, 118210000029, 118210000030, 117200568387, 117200568404, 117190568245, 117190568246, 117190568247, 117190568248, 117190568249, 117200568664, 117200568665, 117200568666, 117210570494, 117220571853, 117220571854, 117220571855, 117220571856, 117240573477, 117250575043, 117250574851, 117260576250, 117290578774, 117290579353, 117300579812, 117300579810, 117320581838, 117310581538, 117330582979, 117350583853, 117350583854, 117340583699, 117350583855, 117340583702, 117350584009, 117350584025, 117350584041, 117350584042, 117350584043, 117360584752, 117360585080, 117370585583, 117380586304, 117380586303, 117380587697, 117380587478, 117380587698, 117410589631, 117400589312, 117410589632, 117410589633, 117430591573, 117440593332, 117440593333, 117440593334, 117440593335, 117440593336, 117440593337, 117430592467, 117430592468, 117470596323, 117470596320, 117470596321, 117470596322, 117470596324, 117470596325, 117490599956, 117490599050, 117480597582, 117500600631, 117500600630, 117500600632, 117500600633, 117520603148, 117510602771, 117520603149, 118010605331, 118030607571, 118030607572, 118030607406, 118050609192, 118050609228, 118060610911, 118060610912, 118070613219, 118090615613, 118090615614, 118090615615, 118100617471, 118100617472, 118110618490, 118180634182, 118150627494, 118150627493, 118150627068, 118160628174, 118140626434, 118140626433, 118130624868, 118120622403, 118120622402, 118120622026, 118180634181, 118180635054, 118180635051, 118180635050, 118180634183, 118180635052, 118180635053, 118240001668, 118240001669, 118240001831, 118240001832, 118240001833, 118250001326, 118250001327, 118260000781, 118260000782, 118270000714, 118270000715, 118280001257, 118280001258, 118280001259, 118280001260, 118280001261, 118290000376, 118290000377, 118290000867, 118290001241, 118290001242, 118290001243, 118320001185, 118340000905, 118340000906, 118340000907, 118340000908, 118350000117, 118350000118, 118360000051, 118360000052, 118360000053, 118360000054, 118360000055, 118360000056, 118360000057, 118360000058, 118360000059, 118360000518, 118360000519, 118360000520, 118360000521, 118360000522, 118360000523, 118360000524, 118360000525, 118380001931, 118380001932, 118390000386, 118390000387, 118390000388, 118390000389, 118390000390, 118400000207, 118400000208, 118400000209, 118400000210, 118400000211, 118400000698, 118400000699, 118400000700, 118430001304, 118430001305, 118430001306, 118450001177, 118460001582, 118460001583, 118470000260, 118470000261, 118500000639, 118500000640, 118500000641, 118500000642, 118500000643, 118520000905, 119040000854, 119050000681, 119050000682, 119050000683, 119050000684, 119060001359, 119060001360, 119070000214, 119070000215, 119070000216, 119080000186, 119080000187, 119080000188, 119080000189, 119110000756, 119120001149, 119120001150, 119120001151, 119120001152, 119160000318, 119160000319, 119170000425, 119200001274, 119200001822, 119210001020, 119210001021, 119220000664, 119220000665, 119220001048, 119220001049, 119230002429, 119230002430, 119230002431, 119250000553, 119250001410, 119250001411, 119250001414, 119250001415, 119260000126, 119260000127, 119280001372, 119280001749, 119280001750, 119310000245, 119310000246, 119310000247, 119310000248, 119310001358, 119310001359, 119310001360, 119330000157, 119330000808, 119330000809, 119380001356, 119380001357, 119380001358, 119380001359, 119380001360, 119380001361, 119380001362, 119380001363, 119380001364, 119380001365, 119380001366, 119390001988, 119390001989, 119390001990, 119390000615, 119400000248, 119400000249, 119400000250, 119400000254, 119400000255, 119400001290, 119400001291, 119400001292, 119400001293, 119400001294, 119400001295, 119430001817, 119430001818, 119430001819, 119430001820, 119430001821, 119430001822, 119430001823, 119450001900, 119450001901, 119450001902, 119450001903, 119450001904, 119450001905, 119450001906, 119460001072, 119460001073, 119490000495, 119490000496, 119490000497, 119490000498, 119490000499, 119490000500, 119500000110, 119500000529, 119500000530, 119500000531, 119500000532, 119500000533, 119500001528, 119500001529, 119500001530, 119500001531, 119500001532, 119510000661, 119510000662, 119510000663, 119510000664, 119510000665, 119510001185, 119510001186, 119510001187, 119510001188, 119510001189, 119520000621, 119520000622, 119520000623, 120010000754, 120010000755, 120020001163, 120030000546, 120040000641, 120040000642, 120040000643, 120050000441, 120050000442, 120050000443, 120060000937, 120070001199, 120070001200, 120080000836, 120090001324, 120090001325, 120090001326, 120090001327, 120100000623, 120100000624, 120100000625, 120100000626, 120100001903, 120100001904, 120100001905, 120100001906, 120100001907, 120100001908, 120110002511, 120120000635, 120120000636, 120120000637, 120120000638, 120120001441, 120120001442, 120120001443, 120130000345, 120130000346, 120130000347, 120130001075, 120130001076, 120130001077, 120130001078, 120150002418, 120150002419, 120160001488, 120160001489, 120160001490, 120160001491, 120160001492, 120160001493, 120160001494, 120160001495, 120160001496, 120160001497, 120160001498, 120160001499, 120190000898, 120200001394, 120200001395, 120230001624, 120230001625, 120230001626, 120230002014, 120230002015, 120230002016, 120230002017, 120230002018, 120230002019, 120230002020, 120230002021, 120230002022, 120230002023, 120230002024, 120230002025, 120250000217, 120250000218, 120250000219, 120250000220, 120250000221, 120250000222, 120260000166, 120260000167, 120260000168, 120260000169, 120300000078, 120300001450, 120300001451, 120310001587, 120310001588, 120320000359, 120320000360, 120320000361,

Quantity Affected: 4687 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