Surveyor S19 recallZ-1484-2021 · 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-1484-2021
- Status
- Terminated
- Initiated by the company
- Mar 31, 2021
- Recalling firm
- Welch Allyn Inc Mortara
- Quantity
- 213 units
- Product code
- DPS
- FDA submissions
- K173765
- 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
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.
Code information (models, lots, serial numbers)
Show the full code information (5k characters)
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
Devices named in this recall
28 devices in the FDA device registry whose identifier appears in the recall's code information.
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall2 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901138Welch Allyn, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Surveyor S19 SUR19-YAG-EXXBXMortara Instrument, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- Surveyor S19 SUR19-ZAG-EXXBXMortara Instrument, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- Surveyor S12 SUR12-RAG-EXABXMortara 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-1485-2021 · TerminatedAM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
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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