FDA Recall Open, Classified

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

Recall: Z-1994-2025 · Initiated May 9, 2025

Recall

Recall Number
Z-1994-2025
Event Number
96885
Firm
Barco N.V. President Kennedypark 35 Kortrijk Belgium
FEI Number
3004455125
Product Code
DXJ
Status
Open, Classified
Root Cause
Nonconforming Material/Component
Initiated
May 9, 2025
Posted
June 20, 2025

Description

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

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

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

Distribution

US Nationwide distribution in the states of TX, OH.

Quantity

221