AM12M recallZ-1485-2021 · Welch Allyn Inc Mortara · initiated Mar 31, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Welch Allyn Inc Mortara or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Devices do not meet IEC 60601-2-27 requirements as labeled.
FDA root cause category: Process control
What the company is doing
Recall notification letters were mailed to customers notifying them of the potential issue with recommended actions beginning April 7, 2021. The notification letter includes an acknowledgement form that must be returned to the recalling firm. Once the customer confirms the impacted units are in possession, the recalling firm will arrange for an exchange AM12M to be provided. The recalled unit will be returned to the recalling firm's service center for processing.
Recall details
- Recall number
- Z-1485-2021
- Status
- Terminated
- Initiated by the company
- Mar 31, 2021
- Recalling firm
- Welch Allyn Inc Mortara
- Quantity
- 746 units
- Product code
- DPS
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.
Product description
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.
Code information (models, lots, serial numbers)
Show the full code information (11k characters)
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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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, 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Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- AM12M 41000-037-50Mortara Instrument, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- AM12M 41000-037-51Mortara Instrument, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- AM12M 9293-065-50Mortara Instrument, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 87686).
- Z-1482-2021 · TerminatedELI 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 pediat…
- Z-1483-2021 · TerminatedELI 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 pediat…
- Z-1484-2021 · TerminatedSurveyor 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 ad…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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