Z-0707-2024Class II

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

Name: Z-0707-2024 XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT...
Creator: Baxter Healthcare Corporation
Published: 2023-12-08
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-12-08 / Open, Classified / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of 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... on 2023-12-08. FDA classified it as Class II and gives the reason as "Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0707-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-08
Posted: 2024-01-10
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
Product code: DPS Electrocardiograph
Reason for recall: Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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, 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122420000194, 122420000195, 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0707-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0705-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-10
Z-0706-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-10
Z-0707-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-10

Product code DPS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)