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; components of the NexxisOR system
FDA Recall Z-1994-2025 · Posted 2025-06-20
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Recalling FirmBarco N.V.
Recall StatusOpen, Classified
Product CodeDXJ
Date Initiated2025-05-09
Product Quantity221
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
Firm Action
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
Distribution Pattern
US Nationwide distribution in the states of TX, OH.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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