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U.S. Department of Health and Human Services

Class 2 Device Recall Surveyor S12/S19

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  Class 2 Device Recall Surveyor S12/S19 see related information
Date Initiated by Firm March 31, 2021
Create Date April 22, 2021
Recall Status1 Completed
Recall Number Z-1484-2021
Recall Event ID 87686
510(K)Number K173765  
Product Classification Electrocardiograph - Product Code DPS
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.
Code Information 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 
Recalling Firm/
Manufacturer		 Welch Allyn Inc Mortara
7865 N 86th St
Milwaukee WI 53224-3431
For Additional Information Contact Welch Allyn Technical Support
888-667-8272
Manufacturer Reason
for Recall		 Devices do not meet IEC 60601-2-27 requirements as labeled.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DPS and Original Applicant = Mortara Instrument, Inc.
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