Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320 — Class II medical device recall Z-1994-2025
Ongoing recall by Barco N.V., reported 2025-07-02, distributed nationwide. Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more
| Recall number | Z-1994-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Barco N.V., Kortrijk, Belgium |
| Recall initiated | 2025-05-09 |
| Classified | 2025-06-20 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 221 |
| UPC / GTIN / UDI-DI | 05415334002180, 05415334002364, 05415334026810, 05415334026827 |
| Serial numbers | 2531531604, 2531533289, 2531533292, 2531533293, 2531533304, 2531533310, 2531533312, 2531533314, 2531533316, 2531533353, 2531533356, 2531534284, 2531534292, 2531534362, 2531534397, 2531534420, 2531534430, 2531534466, 2531534905, 2531534948, 2531534956, 2531536564, 2531537696, 2531537718, 2531537726 and 194 more |
| Model numbers | H/K9303320, MNA-420, MNA-420DEC, MNA-420ENC, V2/K9303331 |
Product
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
Reason for recall
Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video and/or control signals might be interrupted or fall away, displays might switch to failover and back multiple times, devices/sources/sinks might not be discovered/available, might lead to delayed/prolonged procedures
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-1994-2025. 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.