Recall Z-2332-2024— Barco N.V.

Class II · Completed

Class II FDA medical device recall by Barco N.V., initiated 2024-04-24. It names one FDA 510(k) clearance: K173381. Product: MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display. 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..

Recalling firm
Barco N.V.
Classification
Class II
Status
Completed
Initiated
2024-04-24
Firm location
Kortrijk, N/A, Belgium

510(k) clearances named in this recall

1 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.