The Recall Desk
HighFDA (Devices)·Z-1994-2025·Announced 2025-07-02

Operating room display components recalled for duplicate MAC address configuration issue

Barco NexxisOR surgical system encoder and decoder components can fail to function reliably when multiple units share the same MAC address, potentially interrupting audio, video, and control signals. The recall affects 221 units in Texas and Ohio.

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: FDA Class II medical device with potential for procedural delay and system failure in operating room context. No injuries or illnesses reported. This is a risk-of-harm product where injury has not yet occurred, meeting the criterion for High severity.

Plain-English summary

Barco N.V. is recalling specific encoder and decoder components of the NexxisOR operating room display system (models MNA-420, MNA-440, MNA-620, and MNA-640). When two or more affected units are configured together in a new system setup, they share the same MAC (Media Access Control) address, preventing proper network communication.

This configuration issue causes the system to function unreliably. Audio, video, and control signals may be interrupted or lost entirely. Displays may switch to failover mode and back repeatedly. Devices, sources, and sinks may not be discovered or available, potentially leading to delayed or prolonged surgical procedures.

The recall affects 221 units distributed in Texas and Ohio. Affected units are identified by their reference numbers (REF) and serial numbers provided by the manufacturer. Healthcare facilities should contact Barco N.V. to determine if their systems are affected and to obtain instructions for correction or replacement.

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 — Operating Room Display System
Hazard
  • device-malfunction
  • signal-loss
  • delayed-procedure

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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