RegWardenFDA facility compliance records
Company

BARCO NV

7 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2015: 1 recalls; 2017: 1 recalls; 2021: 1 recalls; 2022: 1 recalls; 2023: 1 recalls; 2024: 1 recalls; 2025: 1 recalls1201520161201720182019202012021120221202312024120252026
  • Recalls (7)

Registered facilities (5)

Recalls & enforcement

  • Class IIOngoing2025-05-09
    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 …
  • Class IICompleted2024-04-24
    We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDMI or MNA-4x0 ENC HDMI. In some instances, this connection may render the first HDMI channel inaccessible, making both th…
  • Class IIOngoing2023-12-20
    Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MNA decoder is blocked.
  • Class IIOngoing2022-07-27
    installation issues
  • Class IITerminated2021-01-22
    A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.
  • Class IITerminated2017-03-30
    If metal strips are removed and re-applied to another display, there is potential for the metal strips to be deformed resulting in a smaller contact surface with the front cover magnet strips. There is a risk that the protective front cover could come loose and may fall down.
  • Class IITerminated2015-05-28
    User settings were no longer on the monitor's memory after these systems were powered off and back on.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “BARCO NV — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9031117-barco-nv/

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