NIM Vital Patient Interface 4 — Class II medical device recall Z-1224-2022
Ongoing recall by Medtronic Xomed, Inc., reported 2022-06-08, distributed nationwide. Software anomaly was identified.
| Recall number | Z-1224-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Xomed, Inc., Jacksonville, FL, United States |
| Recall initiated | 2022-05-03 |
| Classified | 2022-06-02 |
| Reported by FDA | 2022-06-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR |
| Quantity | 29 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000002985, 00763000395902 |
| Lot numbers | P1910256, P1910260, P1910402, P1910404, P2008073, P2008130, P2008131, P2026275, P2026290, P2026329, P2026330, P2026357, P2026388, P2026389, P2026680, P2026681, P2026718, P2026719, P2026793, P2026956, P2026957, P2026958, P2026959, P2026981, P2026994, P2026995, P2127005, P2127006, P2127013 |
| Model numbers | NIM4CPB1 |
Product
NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Reason for recall
Software anomaly was identified.
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-1224-2022. 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.