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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Welch Allyn Inc Mortara: Devices do not meet IEC 60601-2-27 requirements as labeled.

Agency Publication Date: April 22, 2021
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Affected Products

Product: ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.

Part Number: ELI280-LDB-ADAAX (Device Identifier: 732094265699); S/N: 117030550918 and 117030550919 Part Number: ELI280-LDD-AAABX (Device Identifier: 732094265682); S/N: 117260576403 Part Number: ELI280-LDX-ADABX (Device Identifier: 732094265675); S/N: 118240001697 and 118150627678 Part Number: ELI280-LDX-ADFBD (Device Identifier: 732094265644); 118230000580, 118230000570, 118230000584, 118230000569, 118230000572 118230000582, 118230000574, 118230000576, 118230000577, 118230000581, 118230000568, 118230000575, 118230000583, 118230000578, 118230000571, 118230000567, 118340001621, 118340001622, 118340001623, 118400001475, 118400001471, 118400001472, 118400001476, 118400001467, 118400001470, 118400001469, 118400001482, 118400001477, 118400001481, 118400001478, 118400001479, 118400001480, 118420000070, 118420000071, 118420000065, 118420000067, 118420000068, 118420000066, 118420000069, 118430000923, 118430000946, 118430000930, 118430000932, 118430000928, 119150000011, 119150000001, 119150000002, 119150000003, 119150000010, 119150000008, 119150000009, 119150000004, 119150000007, 119180000631, 119180000632, 119180000633, 119180001155, 119180001156, 119180001153, 119180001154, 119180001157, 119260000043, 119260000442, 119260000443, 119280001568, 119270000064, 119290001054, 119290001053, 119290001048, 119290001052, 119290001050, 119290001049, 119290001051, 119290001055, 119470001878, 119470001879, 119510000132, 119510000135, 119510000134, 119510000133, 120080000860, 120050001405, 118120622367, 118180633837, 118180633838, 118180633839, 118180633840, 118190635342, 118190635353 Part Number: ELI280-LDX-ADFBG (Device Identifier: 732094319941); S/N: 119480000195, 119480000191, 119480000193, 119480000194, 119480000192

Product: ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.

Part Number: ELI380-ACX32 (Device Identifier: 732094265415); S/N: 118490001284, 119150000588, 120090001355, 120090001354 Part Number: ELI380-DAX3X (Device Identifier: 812345026757); S/N: 117120557018, 117120557019, 117120557020, 117120557021, 117230571942, 117230571943, 117270577469 Part Number: ELI380-DBX32 (Device Identifier: 732094265262); S/N: 118180634420 Part Number: ELI380-DCX32 (Device Identifier: 732094265187); S/N: 118340001074, 118340001074, 118340001075, 118500001332, 118460001178, 119150000120, 119210000774, 119290000580, 119520000194, 120080001509, 120080001510, 120100000310, 120080001511, 120110002478, 120170000570

Product: Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.

Part Number: SUR19-FDH-XXXAX (Device Identifier: 732094288926); S/N: 118300000441, 118300000440, 118300000438, 118300000439, 118350000999, 118350000998, 118350000997, 118350000996, 119100001366, 119100001369, 119100001367, 120140001434, 120140001435 Part Number: SUR19-LDH-BXXAX (Device Identifier: 732094261585); S/N: 117430592474, 117430592471, 117430592472, 117430592473, 117430592475, 117430592476 Part Number: SUR19-LDH-XXXAX (Device Identifier: 732094261578); S/N: 118310000505, 118340000831, 118310000507, 118310000508, 118310000509, 118310000506, 118400001602, 118400001604, 118400001603, 118350001163, 118350001162, 118350001164, 118350001161, 118400001598, 118400001595, 118400001597, 118400001596, 118400001606, 118400001611, 118400001609, 118400001607, 118400001605, 118400001608, 118430002495, 118430002491, 118430002494, 118430002492, 118400001610, 118430002493, 118450000075, 118430002499, 118430002498, 118430002497, 118430002496, 118480000758, 118480000758, 117370585641, 117370585642, 117370585643 Part Number: SUR19-SDH-XXXAX (Device Identifier: 732094261547); S/N: 118210000018, 118430002502, 118430002502, 118430002501, 119080000312, 117370585652, 118020606826, 117410589967, 117410589968, 117410589969, 117410589970,118100618343, 118100618344, 118100618345, 118100618346, 118100618347, 118100618348, 118100618349, 117410589971, 118170632916, 117410589972, 117410589973, 117410589974, 117460595075, 117460595076, 117460595077, 117460595078, 117460595079, 117460595080, 117460595081 Part Number: SUR19-TDH-XXXAX (Device Identifier: 732094261516); S/N: 118230000778, 118230000779, 118230000777, 118230000776, 118340000836, 118340000839, 118340000835, 118340000838, 118340000834, 118340000837, 118480000760, 117380586829, 117380586830, 117380586831, 117380586832, 117380586833 Part Number: SUR19-TDH-XXXBX (Device Identifier: 732094301700); S/N: 118480000321, 118480000320, 118460001599, 118460001598, 118480000319, 118480000323, 118460001604, 118460001597, 118460001604, 118480000322, 118460001603, 118460001601, 118460001602 Part Number: SUR19-XDH-BAXAX (Device Identifier: 732094261509); S/N: 117480597039, 117480597040 Part Number: SUR19-XDH-XXXAX (Device Identifier: 732094321449); S/N: 119300000518, 119300000517, 119300000519, 119300000516, 119300000520, 119340001905, 119340001910, 119340001912, 119340001906, 119340001903, 119340001908, 119340001911, 119340001907, 119340001909, 119340001904 Part Number: SUR19-YAG-EXXBX (Device Identifier: 817655021539); S/N: 117220571844 Part Number: SUR19-YDH-XXXAX (Device Identifier: 732094321210); S/N: 119300000514 Part Number: SUR19-ZAG-EXXBX (Device Identifier: 817655021546); S/N: 117440593338 Part Number: SUR19-ZDH-XXXAX (Device Identifier: 732094283563); S/N: 119360000823, 119360000826, 119360000825, 119360000822, 119360000824, 119360000821, 116350524606 Part Number: SUR19-ZDH-XXXBX (Device Identifier: 732094261486); S/N: 117390588069, 118120622042 Part Number: SUR12-ADH-XXXAX (Device Identifier: 732094284409); S/N: 119040000857, 119360000823, 119360000826, 119360000825, 119360000822, 119360000824, 119360000821, 116350524606 Part Number: SUR12-FDH-XXXAX (Device Identifier: 732094261790); S/N: 118250001742, 118250001744, 118250001743, 118350001118, 118350001119, 118350001117, 119360000823, 119360000826, 119360000825, 119360000822, 119360000824, 119360000821, 116350524606, 117260576394, 117260576395, 117260576396, 117260576397 Part Number: SUR12-FDH-XXXBX (Device Identifier: 732094261783); S/N: 118420000002, 118420000001, 119360000823, 119360000826, 119360000825, 119360000822, 119360000824, 119360000821, 119480000130, 120170000342, 120170000343, 120170000344, 116350524606, 118140625968 Part Number: SUR12-LDH-BXXAX (Device Identifier: 732094261745); S/N: 117240573496, 117240573497 Part Number: SUR12-LDH-XXXBX (Device Identifier: 732094261738); S/N: 119350003286, 119350003285, 119350003289, 119350003288, 119350003287, 120050001589, 120050001590, 120050001592, 120050001589, 117370585648, 117370585649, 117370585650, 117370585651 Part Number: SUR12-RAG-DAABX (Device Identifier: 732094294262); S/N: 118340000584 Part Number: SUR12-RAG-EXABX (Device Identifier: 817655021553); S/N: 117220571843 Part Number: SUR12-RDF-XXXAX (Device Identifier: 732094296419); S/N: 118350001122, 118350001124, 118350001125 Part Number: SUR12-RDH-BXAAX (Device Identifier: 732094283921); S/N: 118260000876, 118260000876, 116350524568 Part Number: SUR12-RDH-XXXBX (Device Identifier: 732094294811); S/N: 118320000124 Part Number: SUR12-SDH-XXABX (Device Identifier: 732094261714); S/N: 117390588070 Part Number: SUR12-TDH-XXXBX (Device Identifier: 732094319354); S/N: 119350003282, 119350003284, 119350003283, 119350003281, 120140000838, 120140000839, 120140000840, 120140000842, 120140000841, 120140000843 Part Number: SUR12-UAG-XBABX (Device Identifier: 732094294279); S/N: 118340000585 Part Number: SUR12-UDH-XXXBX (Device Identifier: 732094261646); S/N: 118450001169, 118450001174, 118450001173, 118450001175, 118450001172, 118450001170, 118450001171, 118450001176, 117480597041, 117480597593, 117480597594, 117480597595 Part Number: SUR12-WBE-XXXAX (Device Identifier: 732094288636); S/N: 118340002358

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 populations.

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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87686
Status: Resolved
Manufacturer: Welch Allyn Inc Mortara
Manufactured In: United States
Units Affected: 4 products (99 units; 27 units; 213 units; 746 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.