High FDA (Devices)·Z-1994-2025·Announced 2025-07-02

Barco NexxisOR System Display Encoders and Decoders Recalled

Barco N.V. is recalling certain NexxisOR system display encoder and decoder models due to duplicate MAC addresses that can cause system malfunction, audio/video interruptions, and delayed procedures when multiple units are deployed together.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a medical device with a risk-of-harm defect (system malfunction, signal interruptions, delayed procedures). The source text does not report any actual illnesses or injuries, and the hazard is based on the potential for system failure. Under the rubric, this qualifies as High (score 3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Barco N.V. is recalling certain models of cathode ray tube display system encoders and decoders that are components of the NexxisOR system. The recalled models include MNA-420, MNA-440, MNA-620, and MNA-640 units in various configurations. A total of 221 units were distributed nationwide.

The encoders and decoders have the same MAC address, which causes reliability problems when two or more affected units are set up together in a new system. This duplicate MAC address issue can lead to audio, video, and control signal interruptions or complete signal loss. Displays may switch to failover mode and back multiple times, and connected devices, sources, and sinks may not be discovered or remain unavailable. These failures can result in delayed or prolonged medical procedures.

If you own or operate any of the recalled units, contact Barco N.V. for instructions on how to address this issue. The specific affected serial numbers are listed in the recall documentation, and units distributed in TX and OH should verify their serial numbers against the provided list.

The recalled product

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; comp
Manufacturer: Barco N.V.
Category: Medical Device — Display System Components
Hazard: system-malfunction
signal-interruption
device-discovery-failure
Affected units: 221

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

REF/UDI-DI/Serial Number: K9303320/05415334002364/2531531598
2531531604
2531534397
2531534420
2531534430
2531534466
2531534905
2531534948
2531534956
2531536564
2531554560
2531572616
2531572628
2531572634
2531591962
2531591973
2531591992
2531592064
2531592096
2531593814

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Barco N.V.

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