Baxter Healthcare Corporation: 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

Recall number

Z-0707-2024

Recalling firm

Baxter Healthcare Corporation

Product

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

Status

Open, Classified

Initiated

2023-12-08

Posted

2024-01-10

Terminated

not on file

Reason

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

Root cause

Software design

Action

Baxter issued an Urgent Medical Device Correction notice to its consignees on 12/08/2023 via USPS first class mail. The notice explained the problem, hazard involved, requested the following actions be taken until a software update becomes available: - Clinicians should evaluate the potential impact of the SCF as described to determine if it should be enabled or disabled during stress testing and provided the method for disabling the setting. - If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them, informing them of the requirement to evaluate the potential impact of the SCF during stress testing. - Respond using the customer portal: https://BaxterFieldActionCustomerPortal.onprocess.com. - If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box on the customer portal. - If you purchased this product from a distributor, please note that the Baxter reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to your distributor/wholesaler according to their instructions. For general questions regarding this communication, contact Baxter (legacy Welch Allyn and Hillrom) Customer Service at 800-535-6663, Option 1, or Option 2 for Technical Support, between the hours of 8:00 am and 8:00 pm Eastern Time, Monday through Friday.

Quantity

1675 units

Distribution

United States (including Puerto Rico), Canada, Australia, Bangladesh, Brunei, Chia, Hong Kong, India, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Thailand, Algeria, Angola, Austria, Bahrain, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Argentina, Bahamas, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, and Trinidad and Tobago.

Lot, serial or model codes

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, 119110000128, 119110000131, 119130001329, 119130001330, 119170000064, 119170000066, 119170000067, 119170000068, 119190000633, 119190000634, 119190000635, 119190000629, 119190000630, 119190000636, 119190000637, 119170000054, 119170000061, 119190000628, 119190000631, 119190000632, 119170000055, 119170000056, 119170000062, 119170000063, 119170000065, 119170000057, 119170000058, 119170000059, 119170000060, 119240001197, 119240001198, 119340000071, 119340000072, 119340000073, 119340000074, 119340000075, 119340000076, 119340000077, 119340000078, 119340000079, 119340000080, 119350002675, 119350002676, 119350002677, 119350002678, 119350002679, 119350002680, 119350002681, 119350002682, 119350002683, 119350002684, 119380001144, 119380001145, 119380001146, 119380001147, 119380001148, 119380001149, 119430001324, 119430001325, 119430001326, 119430001327, 119430001328, 119430001329, 119430001330, 119430001331, 119430001332, 119430001333, 119470001107, 119470001108, 119470001109, 119470001110, 119470001111, 119470001112, 119470001113, 119470001114, 119470001115, 119470001116, 119500000427, 119500000428, 119500000429, 119500000430, 119500000431, 119500000432, 119500000433, 119500000434, 120080000436, 120080000437, 120080000438, 120080000439, 120080000440, 120080000441, 120080000442, 120080000443, 120080000444, 120080000445, 120080000446, 120080000447, 120080000448, 120080000449, 120080000450, 120080000451, 120080000452, 120080000453, 120080000454, 120080000455, 120260000436, 120260000437, 120260000438, 120370001869, 120370001870, 120370001872, 120260000439, 120260000440, 120370001871, 120370001873, 120370001874, 120370001875, 120370001876, 120370001877, 120370001878, 120410001420, 120410001421, 120410001422, 120410001423, 120410001424, 120410001425, 120410001426, 120410001427, 120480000382, 120480000383, 120480000384, 120480000385, 120480000386, 120480000387, 120480000388, 120480000389, 120480000390, 120480000391, 120480000392, 120480000393, 120480000394, 120480000395, 120520000178, 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122420000201, 122420000202, 122450001786, 122450001787, 122450001788, 122450001789, 122450001790, 122450001791, 123100000063, 123100000069, 123100000070, 123100000071, 123100000064, 123100000065, 123100000066, 123100000067, 123100000068, 123130001066, 123130001067, 123210000710, 123210000711, 123340001553, 123340001554, 123320000551, 123320000552, 123370000077, 123370000078, 123370000079, 123370000080, 118050610039, 118180634937, 118050609198, 118180634937, 121450000127, 121450000128, 121460000618, 122230000033, 122230000034, 122230000035, 122230000036, 122230000037, 122230000038, 122230000039, 122230000040, 122230000041, 122230000042, 122230000043, 122230000044, 122500000829, 122500000830, 122500000831, 116480540886, 116480540887, 116480540885, 116480540888, 116480540889, 116480540890, 116480540891, 116500543972, 116530547195, 116530547196, 116530547197, 116530547198, 116530547199, 116530547200, 116530547201, 116530547207, 116530547208, 116530547209, 116530547202, 116530547203, 116530547204, 116530547205, 116530547206, 117050552991, 117050552992, 117140561292, 117140561293, 117140561294, 117140561295, 117140561296, 117140561297, 117140561299, 117140561300, 117140561301, 117140561302, 117190567099, 117190567100, 117140561298, 117190567101, 117190567102, 117190567103, 117190567104, 117190568321, 117190568322, 117190568323, 117210570066, 117250575592, 117250575593, 117250575594, 117250575595, 117250575596, 117250575597, 117260576261, 117260576262, 117260576263, 117250575598, 117250575599, 117250575600, 117250575601, 117310581178, 117310581179, 117350584646, 117350584647, 117350584648, 117350584649, 117350584650, 117350584642, 117350584643, 117400589264, 117400589265, 117400589266, 117400589267, 117400589268, 117400589293, 117400589294, 117400589295, 117400589296, 117400589297, 117400589298, 117400589299, 117400589269, 117400589270, 117400589271, 117400589272, 117400589273, 117400589274, 117430591637, 117430591638, 117430591639, 117430591640, 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

510(k) numbers

not on file

PMA numbers

not on file

Product code

DPS

Firm FEI

1417572

Firm city

Deerfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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