Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300,
FDA device recall Z-1994-2025 · posted 2025-06-20 · Open, Classified
Recall details
- Recalling firm
- Barco N.V.
- Reason for recall
- 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
- Action taken
- On 5/9/2025, recall notices started being distributed to customers informing them of the following: 1) Assess & locate the non-installed affected units and contain them from further distribution. B) Assess & locate affected units that are installed at your customer side. Please make your customers aware of this notification. C) The impacted units will need to be sent back. Further information on the swaps will be provided in the coming days. D) Fill in and return the Acknowledgement Letter. If you don t have the Key Account Manager s contact details, or need other support, you can contact the firm 24/7 via their Support web page: https://www.barco.com/en/support
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- DXJ
- Quantity affected
- 221
- Distribution
- US Nationwide distribution in the states of TX, OH.
- Date initiated
- 2025-05-09
- Date posted
- 2025-06-20
- Location
- Kortrijk, Belgium
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Nexxis OR (K173381) | Barco N.V. | 2018-02-22 |