AM12M Acquisition Module accessory. Impacted software recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part Number: 41000-037-50 (Device Identifier: 812345029666); S/N: 119030001449, 119030001451, 119030001447, 119030001450, 119190000644, 117200568671, 116520545406, 118030607566, 117510602011, 117060553537, 118030607568, 118030607569, 118030607570, 117270577273, 117200568670, 117060553536, 117120556677, 117220571046, 116530547186, 118180635011, 116510544918 Part Number: 41000-037-51 (Device Identifier: 812345029673); S/N: 118330001224, 118330001229, 118330001226, 118330001222, 118330001221, 118330001223, 118330001225, 118330001228, 118330001230, 118330001227, 118370000736, 118350001181, 118410000928, 118410000929, 119140000221, 119140000222, 119140000223, 119420001690, 120070000301, 120070000300, 120070000297, 120070000302, 120070000295, 120070000299, 120070000296, 120070000298, 118070612689, 116440535497, 116440535498, 116440535499, 116440535500, 116530547301, 116530547302, 116530547303, 116530547304, 117040552121, 117040552122, 117040552123, 117040552124, 118130624261, 118130624262 Part Number: 9293-065-50 (Device Identifier: 812345029710); S/N: 118260000305, 118260000306, 118260000307, 118260000308, 118260000309, 118260000310, 118260000311, 118260000855, 118260000856, 118260000857, 118260000858, 118260000859, 118260000860, 118260000861, 118260000862, 118290001080, 118290001081, 118290001082, 118290001083, 118290001084, 118290001085, 118290001088, 118290001090, 118290001091, 118290001093, 118290001094, 118290001097, 118330000945, 118330000946, 118330000950, 118330000952, 118340001214, 118340001215, 118340001221, 118380002053, 118380002063, 118410000049, 118410000050, 118410000053, 118410000055, 118410000056, 118410000057, 118410000058, 118410000059, 118410000060, 118410000061, 118410000063, 118410000065, 118410000066, 118410000067, 118410000113, 118410000114, 118450000570, 118450000571, 118450000572, 118450000573, 118450000574, 118450000575, 118450000576, 118450000577, 118450000578, 118450000579, 118450000580, 118450000581, 118450000582, 118450000583, 118450000584, 118450000585, 118450000586, 118450000587, 118450000588, 118450000589, 118450000615, 118450000617, 118450000619, 118450000621, 118450000622, 118450000627, 118450000629, 118450000630, 118450000631, 118450000632, 118450000633, 118450000634, 118450000635, 118450000636, 118450000637, 118450000638, 118450000639, 118450000640, 118450000645, 118450000659, 118450000667, 118450000669, 119120000451, 119120000452, 119120000454, 119120000455, 119120000456, 119120000457, 119120000459, 119120000460, 119120001224, 119120001234, 119120001235, 119120001237, 119120001238, 119120001240, 119120001246, 119120001247, 119120001248, 119120001249, 119120001250, 119120001251, 119120001252, 119120001253, 119120001254, 119120001255, 119120001256, 119120001257, 119120001258, 119120001259, 119120001260, 119120001261, 119120001262, 119120001263, 119120001264, 119120001265, 119120001266, 119120001267, 119120001268, 119120001269, 119120001270, 119120001271, 119120001272, 119120001273, 119120001274, 119120001275, 119120001276, 119120001277, 119120001278, 119120001279, 119120001280, 119120001281, 119120001282, 119160000351, 119160000352, 119160000353, 119160000354, 119160000355, 119160000356, 119160000357, 119160000358, 119160000359, 119160000360, 119180000721, 119180000722, 119180000723, 119180000724, 119180000725, 119180000726, 119180000727, 119180000728, 119180000729, 119180000730, 119180000731, 119180000732, 119180000733, 119180000734, 119180000735, 119180000737, 119180000738, 119180000743, 119180000744, 119190000996, 119190000997, 119190000998, 119190000999, 119190001000, 119190001001,,, 119190001002, 119190001003, 119190001004, 119190001005, 119190001381, 119190001382, 119190001383, 119190001384, 119190001385, 119190001386, 119190001387, 119190001388, 119190001389, 119190001390, 119190001391, 119190001392, 119190001393, 119190001394, 119190001395, 119230000110, 119230000111, 119230000112, 119230000113, 119230000114, 119230000115, 119230000116, 119230000117, 119230000118, 119230000119, 119240000023, 119240000027, 119240000028, 119240000029, 119320000542, 119320000543, 119320000544, 119320000545, 119320000546, 119320000547, 119320000548, 119320000549, 119320000550, 119320000551, 119320000552, 119320000553, 119320000554, 119320000555, 119320000556, 119320000559, 119430001094, 119430001095, 119430001096, 119430001097, 119430001098, 119430001099, 119430001100, 119430001102, 119430001103, 119430001104, 119430001105, 119430001106, 119430001107, 119430001108, 119430001109, 119450001213, 119450001214, 119450001215, 119450001216, 119450001217, 119450001218, 119450001219, 119450001220, 119450001221, 119450001222, 119450001223, 119450001224, 119450001225, 119450001226, 119450001227, 119450001228, 119450001229, 119450001230, 119450001231, 119450001232,, 120060000612, 120060000613, 120060000614, 120060000615, 120060000616, 120060000627, 120060000628, 120060000629, 120060000630, 120060000631, 120060000632, 120060000633, 120060000634, 120060000635, 120060000636, 120110001720, 120110001721, 120110001722, 120110001723, 120110001724, 120140000961, 120140000964, 120140002418, 120140002421, 120140002422, 120140002423, 120140002425, 120140002426, 120140002428, 120140002429, 120140002430, 120140002433, 120140002437, 120140002438, 120140002444, 120140002447, 120140002448, 120140002451, 120140002452, 120140002453, 117160563851, 117500600575, 116390529419, 116490542198, 118180634091, 116470539365, 116470539366, 118040608361, 117030550967, 117030550968, 117500600568, 117260576877, 117260576884, 116430533868, 117280577903, 118060610984, 117160563854, 117140561705, 118060610981, 118060610967, 118060610995, 117230572782, 117160563852, 116410531264, 117080555200, 117220571047, 116530547331, 118180634101, 117390588733, 116430533876, 116430533877, 116430533878, 116430533879, 117080555192, 117230572787, 117460595351, 117230572785, 118040608360, 116240475613, 116240475614, 116240475615, 116310521404, 116310521405, 116310521406, 116310521407, 116310521408, 116310521409, 116360525383, 116360525384, 116360525385, 116390529418, 116390529421, 116390529422, 116390529425, 116390529426, 116390529428, 116390529429, 116490542214, 116490542215, 116520545886, 116520545887, 117080555197, 117080555198, 117230572774, 117080555199, 117080555201, 117140561696, 117140561697, 117140561698, 117140561699, 117140561700, 117140561701, 117220571057, 117220571060, 117230572772, 117230572775, 117230572784, 117230572786, 117230572788, 117230572789, 117230572790, 117230572791, 117260576872, 117260576874, 117260576875, 117260576876, 117260576879, 117260576880, 117260576881, 117260576882, 117260576883, 117280577911, 117280577919, 117460595346, 117460595364, 117500600565, 117500600567, 117500600569, 117500600573, 117500600574, 117500600576, 117500600577, 117500600579, 116240475616, 116240475617, 116240475618, 116240475619, 116240475620, 116240475621, 116240475622, 116240475623, 116240475624, 116240475625, 116240475626, 116260496380, 116330522663, 116330522870, 116360525806, 116360525807, 116360525808, 116360525809, 116360525810, 116390529417, 116390529420, 116390529423, 116390529424, 116390529427, 116430533873, 116470539362, 116470539363, 116470539364, 116470539367, 116490542196, 116490542197, 116490542199, 116490542200, 116490542201, 116490542202, 116490542203, 116490542204, 116490542205, 116490542206, 116490542207, 116490542209, 116490542210, 116490542211, 116490542212, 116490542213, 116520545931, 117010548836, 117010548837, 117010548838, 117010548839, 117500600570, 117010548840, 117010548841, 117010548842, 117010548843, 117010548844, 117030550969, 117030550970, 117030550971, 117030550972, 117030550973, 117030550974, 117030550975, 117030550976, 117080555196, 117080555202, 117080555204, 117080555207, 117080555211, 117160563853, 117220571048, 117220571051, 117220571056, 117220571061, 117260576878, 117280577904, 117280577905, 117280577906, 117280577907, 117280577908, 117280577909, 117280577912, 117280577913, 117280577916, 117280577921, 117390588716, 117390588718, 117390588719, 117390588720, 117390588721, 117390588722, 117390588723, 117390588727, 117390588730, 117390588732, 117450593715, 117450593716, 117450593719, 117450593722, 117450593723, 117450593724, 117460595345, 117460595347, 117460595349, 117460595350, 117460595352, 117460595354, 117460595355, 117460595357, 117460595358, 117460595359, 117460595362, 117460595363, 117460595365, 117460595366, 117460595367, 117460595368, 117460595369, 116520545888, 116210444884, 116210444885, 116210444886, 116210444887, 116210444888, 116210444889, 116210444890, 116210444891, 116210444892, 116210444893, 116210444894, 116210444895, 116210444897, 116210444898, 116210444899, 116210444901, 116210444903, 116210444908, 116210444909, 116490542216, 116490542217, 116490542218, 116490542219, 116490542220, 116490542221, 116490542222, 116490542223, 116490542224, 116490542225, 116490542226, 116490542227, 116490542228, 116490542229, 116490542230, 116490542231, 116490542232, 116490542233, 116490542234, 116490542235, 116490542236, 116490542237, 116490542238, 116490542239, 116490542240, 116490542241, 116490542242, 116490542243, 116490542244, 116500542944, 116500542945, 116500542946, 116500542947, 116500542948, 116500542949, 116500542950, 116500542951, 116500542952, 116500542953, 116500542954, 116500542955, 116500542956, 116500542957, 116500542958, 116500542959, 116500542960, 116500542961, 116500542962, 116500542963, 117080555193, 117080555194, 117080555203, 117080555205, 117080555206, 117080555208, 117080555209, 117080555210, 117080555212, 117080555213, 117080555214, 117080555215, 117080555216, 117080555217, 117080555218, 117080555219, 117080555220, 117080555221, 117080555222, 117080555223, 117080555224, 117140561682, 117140561683, 117140561684, 117140561685, 117140561686, 117140561687, 117140561688, 117140561689, 117140561690, 117140561691, 117140561692, 117140561693, 117140561694, 117140561695, 117140561702, 117140561703, 117140561704, 117140561706, 117140561707, 117140561708, 117140561709, 117140561710, 117140561711, 117140561712, 117140561713, 117140561714, 117140561715, 117140561716, 117140561717, 117140561718, 117140561719, 117160563843, 117160563844, 117160563845, 117160563846, 117160563847, 117160563848, 117160563849, 117160563850, 117260576873, 117260576885, 117280577910, 117280577914, 117280577917, 117390587921, 117390587922, 117390587923, 117390587924, 117390587925, 117390587926, 117390587927, 117390587928, 117390587929, 117390587930, 117390587931, 117390587932, 117390587933, 117390587934, 117390587935, 116430533880, 116430533884, 116490542195, 116210444896, 116210444904, 116210444906, 116430533882, 116330522662, 117230572781, 117230572783

Product

AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric…

Recalling firm

Welch Allyn Inc Mortara

Quantity

746 units

Distribution

US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.

Recall date

April 28, 2021

Classification

Class II

Status

Terminated

Agency

FDA (device)