CLASS II Device recall · Reported 28 Apr 2021 · FDA Enforcement Report
AM12M Acquisition Module accessory recalled by Welch Allyn Inc Mortara
Welch Allyn Inc Mortara is recalling AM12M Acquisition Module accessory, distributed nationwide in the US. The recall was initiated on 31 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1485-2021
- FDA event ID
- 87686
- Recalling firm
- Welch Allyn Inc Mortara, Milwaukee, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Mar 2021
- FDA classified
- 22 Apr 2021
- Reported
- 28 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 31 Mar 2021 | Recall initiated by company | |
| 22 Apr 2021 | Classified by FDA | +22 days |
| 28 Apr 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices do not meet IEC 60601-2-27 requirements as labeled.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.
Nationwide CaliforniaColoradoFloridaGeorgiaIndianaLouisianaNorth CarolinaNew JerseyNevadaNew YorkOhioOklahomaTexasUtahVirginia
Questions about this recall
Is AM12M Acquisition Module accessory recalled?
Yes. Welch Allyn Inc Mortara recalled AM12M Acquisition Module accessory on 31 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1485-2021.
Why was it recalled?
Devices do not meet IEC 60601-2-27 requirements as labeled.
Which lots 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, 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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
Where was it sold?
US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Welch Allyn Inc Mortara
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
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