Lower risk Medical device recall · FDA · Published March 31, 2021
Welch Allyn Surveyor S12/S19 Patient Monitors with AM12M Module: Software Version 1.5.1
Welch Allyn recalls Surveyor S12/S19 bedside patient monitors with AM12M acquisition module software version 1.5.1 that do not meet IEC 60601-2-27 safety standards. Affected units have specific serial numbers and part numbers listed in the recall notice.
Lower-risk recall
Devices do not meet IEC 60601-2-27 requirements as labeled.
Contact the company
Recalling firmWelch Allyn Inc Mortara7865 N 86th St · Milwaukee, WI 53224-3431
What happened, in plain English
Welch Allyn is recalling Surveyor S12/S19 bedside patient monitors with AM12M acquisition modules that have software version 1.5.1. The devices do not meet IEC 60601-2-27 safety standards, which could pose a risk to patient safety. Read more at govinfonow.com/recall/62872-welch-allyn-surveyor-s12-s19-patient-monitors-with-am12m-module.
Source Summary by GovInfoNow · govinfonow.com/recall/62872-welch-allyn-surveyor-s12-s19-patient-monitors-with-am12m-module · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1484-2021
Cite this page
“Welch Allyn Surveyor S12/S19 Patient Monitors with AM12M Module: Software Version 1.5.1.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62872-welch-allyn-surveyor-s12-s19-patient-monitors-with-am12m-module. Based on FDA recall #Z-1484-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1484-2021%22&limit=1).
Why it’s dangerous
The devices do not meet IEC 60601-2-27 safety standards, which are designed to ensure medical devices operate safely. This could lead to potential malfunctions that might affect patient monitoring accuracy or safety, though the exact risk is not specified in the recall notice.
Who’s affected
Healthcare providers using the Surveyor S12/S19 bedside patient monitors with AM12M acquisition modules and software version 1.5.1 are most at risk. The recall affects specific units with listed serial numbers and part numbers.
How to tell if you have this one
Check for the part numbers SUR19-FDH-XXXAX, SUR19-LDH-BXXAX, SUR19-LDH-XXXAX, SUR19-SDH-XXXAX, SUR19-TDH-XXXAX, SUR19-ZDH-XXXAX, SUR19-ZDH-XXXBX, SUR12-ADH-XXXAX, SUR12-FDH-XXXAX, SUR12-FDH-XXXBX, SUR12-LDH-BXXAX, SUR12-LDH-XXXBX, SUR12-RAG-DAABX, SUR12-RAG-EXABX, SUR12-RDF-XXXAX, SUR12-RDH-BXAAX, SUR12-RDH-XXXBX, SUR12-SDH-XXABX, SUR12-TDH-XXXBX, SUR12-UAG-XBABX, SUR12-UDH-XXXBX, and SUR12-WBE-XXXAX. The affected units have specific serial numbers listed in the recall notice.
- Brand
Welch Allyn- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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 number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1482-2021 | 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 | 99 units |
| Z-1483-2021 | 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 | 27 units |
| Z-1484-2021 | 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 | 213 units |
| Z-1485-2021 | 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, 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What to do — step by step
Check Device Serial Number
Look for the serial numbers listed in the recall notice (e.g., 118300000441, 118300000440, etc.) on the device or its packaging.
Contact Welch Allyn
Reach out to Welch Allyn directly to confirm if your device is affected and to get instructions on next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 15 states.
FDA distribution: “US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Georgia, Indiana, Louisiana, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Texas, Utah, Virginia.
Recall timeline
FDA terminated this recall 3.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1484-2021 (March 31, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1484-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.