Reported Jan 17, 2024 · Ongoing
Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes
74 of 74 products
| Model / number | Product as published |
|---|---|
QS6 | 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) |
- Lot codes and dates
26 of 26 products
Products covered by this recall # Barcodes Product as published 1 00732094263176116350524925116490541255QS6-BXXCS, UDI/DI 00732094263176, Serial Numbers: 116350524925, 116490541255 2 00732094308716119050000134QS-6CC-DGCXX, UDI/DI 00732094308716, Serial Numbers: 119050000134 3 00732094308723122290000606122230001869122230001868122150001605122150001604122090000843119310001134119240000440122430000522122430000523119050000135QS-6CC-DFCXX, UDI/DI 00732094308723, Serial Numbers: 122290000606, 122230001869, 122230001868, 122150001605, 122150001604, 122090000843, 119310001134, 119240000440, 122430000522, 122430000523, 119050000135 4 00732094263206123170000019QS-6JB-AXAXA, UDI/DI 00732094263206, Serial Numbers: 123170000019 5 116090330912116100344488116100344490116140389225116150394312116180422821116180422823116210442892116220445992116230451848116230455471116260496356116310521226116310521294116310521295116340523119116370526978116400530719116500543975116520546015117090555819117120557453117240573603117240573604117240573605117240573606117250575355117250575356117310581182117320582007117330583105117330583106117420591117117480596687117510602012117520603268118020605912118040608668118050610650118180633950118180633951118250001740118210638580118360000413118360000414118360000415118400000214119090001180119170000426119200000235119250000559119350003341119350003342119400001642119400001643119390002403119450000815119470000523119470000524120190001489120340001206120370000113120390000395120450000603117380587441121040002696121320000296121400000048121420000470QS6-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 6 116110351990116170411313116180422820116190425267116200431781116200435830116200435832116210440257116210442845116220445031116220447262116220447261116220448956116240457509116240461442116240461206116250486048116250485976116250489753116260496350116260496357116260496358116260496359116270498882116280504766116280504767116280505422116290511314116290511315116290516779116300519942116300520698116310521231116310521175116320522055116330522666116340523645116370526300116370526302116380527090116370526980116390528637116380528395116390529243116390529244116390529289116390529290116390529245116390529246116400530260116430534181116440534647116440535722116450535995116460537454116460537582116490541890116500544101116500544003116510545088116520546283116530547307116530547308116530547309116520546501116530547394117010549346117020550273117040551450117030550903117050552567117080554660117110556288117120556595117140562002117170565229117170566105117230572559117230572529117230572792117230572972117240573048117240573453117240573579117280577601117290579316117300580356117320581836117320581837117320582120117380587062117390588108117450593979117450593976117450593977117450593978117480597797117480597798117480597583117480597584117520603269117520603562118040607784118090615610118090615611118140626430118150627079118160628175118150627075118150627074118150627073118150627072118150627071118150627070118150627069118120623174118180633959118180634187118310001237118340000912118340000913118340000914118370000773118380001940118460001584118480000810118490000217118520000406119040000078119110000757119150000254119160000043119190000970119250000554119280001984119290000535119500001105120020000304120100001917120220001572120220001573120230001261120320000243120320000244120300000912120360001047121070000465121070001280121100002344121100002345121130001104121180000761121340000883121370002510121390000795121460001255122200001819122480002102123300001831QS6-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 7 00732094301076123240000013123240000012123240000011123240000010123240000009120400002601120400002600120400002599120400002598120400002597120210000914120210000913120210000912120210000911120210000910120210000909120210000908120210000907120210000906120210000905120210000904120210000903119330001329119330001328119330001327119330001326119330001325119330001324119330001323119320001019119320001018119320001017119320001016119320001015119180001173119180001172119180001171119180001170119110000755118430000951118430000948118430000949123310000826123310000827123310000828123310000829123310000830123430000320123430000321123430000322123430000323123430000324123430000325123430000326123430000327123430000328123430000329QS-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 8 00732094346633123040001807123040001806123040001805123040001804123040001803122510000875122510000874122510000873122510000872122510000871122480001730122480001729122480001728122480001727122480001726122250001966122250001965122250001964122250001963122250001962122240000488122240000487122240000486122240000485122240000484122160000349122160000348122160000347122160000346122160000345122010000998122010000997122010000996122010000995122010000994121490000353121490000352121490000351121490000350121490000349121320000685121320000684121320000683121320000682121320000681121090000175121090000174121090000173121090000172121090000171QS-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 9 00732094355314123400000592123400000593QS-6AC-XXAXA, UDI/DI 00732094355314, Serial Numbers: 123400000592, 123400000593 10 00812345027587116120372696QS6-AXTDS, UDI/DI 00812345027587, Serial Numbers: 116120372696 11 00732094263855118520000406QS-6AC-AXAAA, UDI/DI 00732094263855, Serial Numbers: 118520000406 12 00732094263794116330522481QS-6AC-CXBXA, UDI/DI 00732094263794, Serial Numbers: 116330522481 13 00732094263756116070309986QS-6AC-DXAXA, UDI/DI 00732094263756, Serial Numbers: 116070309986 14 00732094263732117380586614QS-6AC-XXBXA, UDI/DI 00732094263732, Serial Numbers: 117380586614 15 116150390529116210438777116530547233116530547234116530547235QS6-MXTCS, UDI/DI 0081234502767921, Serial Numbers: 116150390529, 116210438777, 116530547233, 116530547234, 116530547235 16 00732094326604119470001903QS-6AC-CGAAB, UDI/DI 00732094326604, Serial Numbers: 119470001903 17 00732094263749117280578329QS-6AC-XAAXA, UDI/DI 00732094263749, Serial Numbers: 117280578329 18 00732094263787117120558685QS-6AC-DEAAX, UDI/DI 00732094263787, Serial Numbers: 117120558685 19 00732094263763117160563895QS-6AC-DFAAX, UDI/DI 00732094263763, 117160563895 20 118200636641QS-6AC-EEBXX, UDI/DI None, Serial Numbers: 118200636641 - Amount recalled
- 4687 units
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
Why it was recalled
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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