Kortrijk, Belgium
Barco N.V. recalls
5 recalls recorded since 2018, most recently on 9 May 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)2
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 May 2025
- Reason
- 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 back multiple times, devices/sources/sinks might not be discovered/available, might lead to delayed/prolonged procedures
- Distribution
- US Nationwide distribution in the states of TX, OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1994-2025
- 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
Completed Class II Medical devices
- Recall started
- 24 April 2024
- Reason
- 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 the channel and the respective MNA ENC unit unusable. Additionally, readings from the module become unavailable when this issue arises. Similarly, when this Molex module is connected to the ETH0 slot of an MNA-620 ENC ANA, readings may also become inaccessible.
- Distribution
- US: FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2332-2024
- MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
Ongoing Class II Medical devices
- Recall started
- 20 December 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution in the state of New Jersey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0979-2024
- Barco MDSC-8527 NXF, Part Number K9352421
Terminated Class II Medical devices
- Recall started
- 22 January 2021
- Terminated
- 18 November 2022
- Reason
- A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.
- Distribution
- WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1172-2021
- Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
Terminated Class II Medical devices
- Recall started
- 30 March 2017
- Terminated
- 4 May 2020
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide Distribution to CA, IL, GA, TX, and WI. In the countries of Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Poland, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0527-2019
- Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119).
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.