Facility

Barco, Inc

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

Key facts

7recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004578804
Establishment type	Repack or Relabel Medical Device; Manufacture Medical Device
Location	3059 Premiere Pkwy DULUTH, GA, US 30097
Registration status	Active · expires 2026
Parent company	BARCO NV (owner-operator 9031117)
Brand names	0240-099-260; 0240-099-255; 0240-031-050; 0240-099-265; 0240-099-250; 0240-031-020

Activity by year

Recalls (7)

Devices registered here (1)

Camera, Television, Surgical, Without Audio
Product code FWB (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4160

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. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Barco, Inc (FEI 3004578804) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004578804-barco-inc/

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