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.
- Company
- Welch Allyn Inc Mortara
- Recall Initiated
- March 31, 2021
- Terminated
- August 16, 2024
- Recall Number
- Z-1484-2021
- Quantity
- 213 units
- Firm Location
- Milwaukee, WI
Reason for Recall
Devices do not meet IEC 60601-2-27 requirements as labeled.
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 / Code Info
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
Root Cause
Process control
Action Taken
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.