Reported Apr 28, 2021 · Terminated

Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the…

Welch Allyn Inc. Mortara

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Welch Allyn Inc Mortara · 7865 N 86th St · Milwaukee, WI · 53224-3431

Is this the product you have?

Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 -
Product Usageindicated for use on adult and pediatric populations

Lot codes and dates: 29 of 29 products
Products covered by this recall
Model / number Barcodes Product as published
SUR19-FDH-XXXAX 732094288926 (Device Identifier: 732094288926)
SUR19-LDH-BXXAX 118300000441118300000440118300000438118300000439118350000999118350000998118350000997118350000996119100001366119100001369119100001367120140001434120140001435732094261585 S/N: 118300000441, 118300000440, 118300000438, 118300000439, 118350000999, 118350000998, 118350000997, 118350000996, 119100001366, 119100001369, 119100001367, 120140001434, 120140001435 (Device Identifier: 732094261585)
SUR19-LDH-XXXAX 117430592474117430592471117430592472117430592473117430592475117430592476732094261578 S/N: 117430592474, 117430592471, 117430592472, 117430592473, 117430592475, 117430592476 (Device Identifier: 732094261578)
SUR19-SDH-XXXAX 118310000505118340000831118310000507118310000508118310000509118310000506118400001602118400001604118400001603118350001163118350001162118350001164118350001161118400001598118400001595118400001597118400001596118400001606118400001611118400001609118400001607118400001605118400001608118430002495118430002491118430002494118430002492118400001610118430002493118450000075118430002499118430002498118430002497118430002496118480000758118480000758117370585641117370585642117370585643732094261547 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 (Device Identifier: 732094261547)
SUR19-TDH-XXXAX 118210000018118430002502118430002502118430002501119080000312117370585652118020606826117410589967117410589968117410589969117410589970118100618343118100618344118100618345118100618346118100618347118100618348118100618349117410589971118170632916117410589972117410589973117410589974117460595075117460595076117460595077117460595078117460595079117460595080117460595081732094261516 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 (Device Identifier: 732094261516)
SUR19-TDH-XXXBX 118230000778118230000779118230000777118230000776118340000836118340000839118340000835118340000838118340000834118340000837118480000760117380586829117380586830117380586831117380586832117380586833732094301700 S/N: 118230000778, 118230000779, 118230000777, 118230000776, 118340000836, 118340000839, 118340000835, 118340000838, 118340000834, 118340000837, 118480000760, 117380586829, 117380586830, 117380586831, 117380586832, 117380586833 (Device Identifier: 732094301700)
SUR19-XDH-BAXAX 118480000321118480000320118460001599118460001598118480000319118480000323118460001604118460001597118460001604118480000322118460001603118460001601118460001602732094261509 S/N: 118480000321, 118480000320, 118460001599, 118460001598, 118480000319, 118480000323, 118460001604, 118460001597, 118460001604, 118480000322, 118460001603, 118460001601, 118460001602 (Device Identifier: 732094261509)
SUR19-XDH-XXXAX 117480597039117480597040732094321449 S/N: 117480597039, 117480597040 (Device Identifier: 732094321449)
SUR19-YAG-EXXBX 119300000518119300000517119300000519119300000516119300000520119340001905119340001910119340001912119340001906119340001903119340001908119340001911119340001907119340001909119340001904817655021539 S/N: 119300000518, 119300000517, 119300000519, 119300000516, 119300000520, 119340001905, 119340001910, 119340001912, 119340001906, 119340001903, 119340001908, 119340001911, 119340001907, 119340001909, 119340001904 (Device Identifier: 817655021539)
SUR19-YDH-XXXAX 117220571844732094321210 S/N: 117220571844 (Device Identifier: 732094321210)
SUR19-ZAG-EXXBX 119300000514817655021546 S/N: 119300000514 (Device Identifier: 817655021546)
SUR19-ZDH-XXXAX 117440593338732094283563 S/N: 117440593338 (Device Identifier: 732094283563)
SUR19-ZDH-XXXBX 119360000823119360000826119360000825119360000822119360000824119360000821116350524606732094261486 S/N: 119360000823, 119360000826, 119360000825, 119360000822, 119360000824, 119360000821, 116350524606 (Device Identifier: 732094261486)
SUR12-ADH-XXXAX 117390588069118120622042732094284409 S/N: 117390588069, 118120622042 (Device Identifier: 732094284409)
SUR12-FDH-XXXAX 119040000857119360000823119360000826119360000825119360000822119360000824119360000821116350524606732094261790 S/N: 119040000857, 119360000823, 119360000826, 119360000825, 119360000822, 119360000824, 119360000821, 116350524606 (Device Identifier: 732094261790)
SUR12-FDH-XXXBX 118250001742118250001744118250001743118350001118118350001119118350001117119360000823119360000826119360000825119360000822119360000824119360000821116350524606117260576394117260576395117260576396117260576397732094261783 S/N: 118250001742, 118250001744, 118250001743, 118350001118, 118350001119, 118350001117, 119360000823, 119360000826, 119360000825, 119360000822, 119360000824, 119360000821, 116350524606, 117260576394, 117260576395, 117260576396, 117260576397 (Device Identifier: 732094261783)
SUR12-LDH-BXXAX 118420000002118420000001119360000823119360000826119360000825119360000822119360000824119360000821119480000130120170000342120170000343120170000344116350524606118140625968732094261745 S/N: 118420000002, 118420000001, 119360000823, 119360000826, 119360000825, 119360000822, 119360000824, 119360000821, 119480000130, 120170000342, 120170000343, 120170000344, 116350524606, 118140625968 (Device Identifier: 732094261745)
SUR12-LDH-XXXBX 117240573496117240573497732094261738 S/N: 117240573496, 117240573497 (Device Identifier: 732094261738)
SUR12-RAG-DAABX 119350003286119350003285119350003289119350003288119350003287120050001589120050001590120050001592120050001589117370585648117370585649117370585650117370585651732094294262 S/N: 119350003286, 119350003285, 119350003289, 119350003288, 119350003287, 120050001589, 120050001590, 120050001592, 120050001589, 117370585648, 117370585649, 117370585650, 117370585651 (Device Identifier: 732094294262)
SUR12-RAG-EXABX 118340000584817655021553 S/N: 118340000584 (Device Identifier: 817655021553)
Page 1 of 2
Amount recalled: 213 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Nationwide
CA
CO
FL
GA
IN
LA
NC
NJ
NV
NY
OH
OK
TX
UT
VA

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Model / number	Barcodes	Product as published
`SUR19-FDH-XXXAX`	`732094288926`	(Device Identifier: 732094288926)
`SUR19-LDH-BXXAX`	`118300000441118300000440118300000438118300000439118350000999118350000998118350000997118350000996119100001366119100001369119100001367120140001434120140001435732094261585`	S/N: 118300000441, 118300000440, 118300000438, 118300000439, 118350000999, 118350000998, 118350000997, 118350000996, 119100001366, 119100001369, 119100001367, 120140001434, 120140001435 (Device Identifier: 732094261585)
`SUR19-LDH-XXXAX`	`117430592474117430592471117430592472117430592473117430592475117430592476732094261578`	S/N: 117430592474, 117430592471, 117430592472, 117430592473, 117430592475, 117430592476 (Device Identifier: 732094261578)
`SUR19-SDH-XXXAX`	`118310000505118340000831118310000507118310000508118310000509118310000506118400001602118400001604118400001603118350001163118350001162118350001164118350001161118400001598118400001595118400001597118400001596118400001606118400001611118400001609118400001607118400001605118400001608118430002495118430002491118430002494118430002492118400001610118430002493118450000075118430002499118430002498118430002497118430002496118480000758118480000758117370585641117370585642117370585643732094261547`	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 (Device Identifier: 732094261547)
`SUR19-TDH-XXXAX`	`118210000018118430002502118430002502118430002501119080000312117370585652118020606826117410589967117410589968117410589969117410589970118100618343118100618344118100618345118100618346118100618347118100618348118100618349117410589971118170632916117410589972117410589973117410589974117460595075117460595076117460595077117460595078117460595079117460595080117460595081732094261516`	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 (Device Identifier: 732094261516)
`SUR19-TDH-XXXBX`	`118230000778118230000779118230000777118230000776118340000836118340000839118340000835118340000838118340000834118340000837118480000760117380586829117380586830117380586831117380586832117380586833732094301700`	S/N: 118230000778, 118230000779, 118230000777, 118230000776, 118340000836, 118340000839, 118340000835, 118340000838, 118340000834, 118340000837, 118480000760, 117380586829, 117380586830, 117380586831, 117380586832, 117380586833 (Device Identifier: 732094301700)
`SUR19-XDH-BAXAX`	`118480000321118480000320118460001599118460001598118480000319118480000323118460001604118460001597118460001604118480000322118460001603118460001601118460001602732094261509`	S/N: 118480000321, 118480000320, 118460001599, 118460001598, 118480000319, 118480000323, 118460001604, 118460001597, 118460001604, 118480000322, 118460001603, 118460001601, 118460001602 (Device Identifier: 732094261509)
`SUR19-XDH-XXXAX`	`117480597039117480597040732094321449`	S/N: 117480597039, 117480597040 (Device Identifier: 732094321449)
`SUR19-YAG-EXXBX`	`119300000518119300000517119300000519119300000516119300000520119340001905119340001910119340001912119340001906119340001903119340001908119340001911119340001907119340001909119340001904817655021539`	S/N: 119300000518, 119300000517, 119300000519, 119300000516, 119300000520, 119340001905, 119340001910, 119340001912, 119340001906, 119340001903, 119340001908, 119340001911, 119340001907, 119340001909, 119340001904 (Device Identifier: 817655021539)
`SUR19-YDH-XXXAX`	`117220571844732094321210`	S/N: 117220571844 (Device Identifier: 732094321210)
`SUR19-ZAG-EXXBX`	`119300000514817655021546`	S/N: 119300000514 (Device Identifier: 817655021546)
`SUR19-ZDH-XXXAX`	`117440593338732094283563`	S/N: 117440593338 (Device Identifier: 732094283563)
`SUR19-ZDH-XXXBX`	`119360000823119360000826119360000825119360000822119360000824119360000821116350524606732094261486`	S/N: 119360000823, 119360000826, 119360000825, 119360000822, 119360000824, 119360000821, 116350524606 (Device Identifier: 732094261486)
`SUR12-ADH-XXXAX`	`117390588069118120622042732094284409`	S/N: 117390588069, 118120622042 (Device Identifier: 732094284409)
`SUR12-FDH-XXXAX`	`119040000857119360000823119360000826119360000825119360000822119360000824119360000821116350524606732094261790`	S/N: 119040000857, 119360000823, 119360000826, 119360000825, 119360000822, 119360000824, 119360000821, 116350524606 (Device Identifier: 732094261790)
`SUR12-FDH-XXXBX`	`118250001742118250001744118250001743118350001118118350001119118350001117119360000823119360000826119360000825119360000822119360000824119360000821116350524606117260576394117260576395117260576396117260576397732094261783`	S/N: 118250001742, 118250001744, 118250001743, 118350001118, 118350001119, 118350001117, 119360000823, 119360000826, 119360000825, 119360000822, 119360000824, 119360000821, 116350524606, 117260576394, 117260576395, 117260576396, 117260576397 (Device Identifier: 732094261783)
`SUR12-LDH-BXXAX`	`118420000002118420000001119360000823119360000826119360000825119360000822119360000824119360000821119480000130120170000342120170000343120170000344116350524606118140625968732094261745`	S/N: 118420000002, 118420000001, 119360000823, 119360000826, 119360000825, 119360000822, 119360000824, 119360000821, 119480000130, 120170000342, 120170000343, 120170000344, 116350524606, 118140625968 (Device Identifier: 732094261745)
`SUR12-LDH-XXXBX`	`117240573496117240573497732094261738`	S/N: 117240573496, 117240573497 (Device Identifier: 732094261738)
`SUR12-RAG-DAABX`	`119350003286119350003285119350003289119350003288119350003287120050001589120050001590120050001592120050001589117370585648117370585649117370585650117370585651732094294262`	S/N: 119350003286, 119350003285, 119350003289, 119350003288, 119350003287, 120050001589, 120050001590, 120050001592, 120050001589, 117370585648, 117370585649, 117370585650, 117370585651 (Device Identifier: 732094294262)
`SUR12-RAG-EXABX`	`118340000584817655021553`	S/N: 118340000584 (Device Identifier: 817655021553)

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This recall covers 4 products

Where it was sold

Why it was recalled

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