AM12M Acquisition Module accessory — Class II medical device recall Z-1485-2021
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-1485-2021 |
|---|---|
| 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 | 746 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00116210444890, 00116210444906, 00116310521408, 00116360525807, 00116390529417, 00116390529424, 00116430533879, 00116440535498, 00116470539367, 00116490542200, 00116490542217, 00116490542224, 00116490542231, 00116500542947, 00116500542954, 00116500542961, 00116530547301, 00117030550969, 00117030550976, 00117080555198, 00117080555204, 00117080555211, 00117140561688, 00117140561695, 00117140561701 and 55 more |
| NDC | 41000-0037-50, 41000-0037-51 |
| Model numbers | 41000-037-50, 41000-037-51, 9293-065-50 |
Product
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-1485-2021. 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.