Surveyor S12/S19 Bedside Patient Monitor — Class II medical device recall Z-1484-2021
Terminated recall by Welch Allyn Inc Mortara, reported 2021-04-28, distributed nationwide. Devices do not meet IEC 60601-2-27 requirements as labeled.
| Recall number | Z-1484-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Welch Allyn Inc Mortara, Milwaukee, WI, United States |
| Recall initiated | 2021-03-31 |
| Classified | 2021-04-22 |
| Reported by FDA | 2021-04-28 |
| Terminated | 2024-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 213 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00116350524568, 00117260576395, 00117370585652, 00117380586830, 00117460595080, 00117480597040, 00118020606826, 00118100618343, 00118250001743, 00118350000998, 00118350001117, 00118350001124, 00118350001162, 00118400001609, 00118420000002, 00118430002492, 00118460001601, 00119300000518, 00119350003286, 00119360000824, 00120140000842, 00732094261486, 00732094261509, 00732094261516, 00732094261547 and 24 more |
| Model numbers | SUR12-ADH-XXXAX, SUR12-FDH-XXXAX, SUR12-FDH-XXXBX, SUR12-LDH-BXXAX, SUR12-LDH-XXXBX, SUR12-RAG-DAABX, SUR12-RAG-EXABX, SUR12-RDF-XXXAX, SUR12-RDH-BXAAX, SUR12-RDH-XXXBX, SUR12-SDH-XXABX, SUR12-TDH-XXXBX, SUR12-UAG-XBABX, SUR12-UDH-XXXBX, SUR12-WBE-XXXAX, SUR19-FDH-XXXAX, SUR19-LDH-BXXAX, SUR19-LDH-XXXAX, SUR19-SDH-XXXAX, SUR19-TDH-XXXAX, SUR19-TDH-XXXBX, SUR19-XDH-BAXAX, SUR19-XDH-XXXAX, SUR19-YAG-EXXBX, SUR19-YDH-XXXAX and 3 more |
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.
Reason for recall
Devices do not meet IEC 60601-2-27 requirements as labeled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1484-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.