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.
- Hazard
- system-malfunction
- signal-interruption
- device-discovery-failure
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.
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