Welch Allyn Inc Mortara: 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.

Recall number

Z-1484-2021

Recalling firm

Welch Allyn Inc Mortara

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.

Status

Terminated

Initiated

2021-03-31

Posted

not on file

Terminated

2024-08-16

Reason

Devices do not meet IEC 60601-2-27 requirements as labeled.

Root cause

Process control

Action

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.

Quantity

213 units

Distribution

US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.

Lot, serial or model codes

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

510(k) numbers

["K173765"]

PMA numbers

not on file

Product code

DPS

Firm FEI

2183461

Firm city

Milwaukee

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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