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Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320… recallZ-1994-2025 · Barco N.V. · initiated May 9, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Barco N.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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

Recall details

Recall number
Z-1994-2025
Status
Open, Classified
Initiated by the company
May 9, 2025
Posted by the FDA
Jun 20, 2025
Recalling firm
Barco N.V.
Quantity
221
Product code
DXJ
FDA submissions
K173381
Distribution
US Nationwide distribution in the states of TX, OH.

Product 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

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

REF/UDI-DI/Serial Number: K9303320/05415334002364/2531531598, 2531531604, 2531534397, 2531534420, 2531534430, 2531534466, 2531534905, 2531534948, 2531534956, 2531536564, 2531554560, 2531572616, 2531572628, 2531572634, 2531591962, 2531591973, 2531591992, 2531592064, 2531592096, 2531593814, 2531593818, 2531593823, 2531597597, 2531610546, 2531610547, 2531610572, 2531610578, 2531610580, 2531612404, 2531612420, 2531612424, 2531612430, 2531612431, 2531612432, 2531612433, 2531612434, 2531612436, 2531612442, 2531623109, 2531623114, 2531623131, 2531623133, 2531623141, 2531635578, 2531635582, 2531639224, 2531639261, 2531639263, 2531639353, 2531640594, 2531640597, 2531640598, 2531640603, 2531640626, 2531640634, 2531540640, 2531640646, 2531640658, 2531640660; K9303331/05415334026827/2531533275, 2531533289, 2531533292, 2531533293, 2531533304, 2531533310, 2531533312, 2531533314, 2531533316, 2531533353, 2531533356, 2531534284, 2531534292, 2531534362, 2531537718, 2531540799, 2531569738, 2531582287, 2531582290, 2531582311, 2531582315, 2531582378, 2531582750, 2531582755, 2531582790, 2531582791, 2531582826, 2531582827, 2531582829, 2531584018, 2531584044, 2531537696, 2531537726; K9303300/05415334002180/2531537815, 2531557845, 2531557866, 2531558588, 2531558727, 2531558738, 2531558753, 2531558754, 2531558759, 2531561761, 2531561785, 2531572541, 2531572557, 2531572568, 2531572576, 2531572847, 2531572862, 2531572872, 2531633606, 2531633662; K9303311/05415334026810/2531537674, 2531572141, 2531580810, 2531580935, 2531582319, 2531582331, 2531582341, 2531588386, 2531588401, 2531588404, 2531588456, 2531591560, 2531592036, 2531592037, 2531592046, 2531593872, 2531594457, 2531594475, 2531594481, 2531594503, 2531594515, 2531597664, 2531597713, 2531597717, 2531597726, 2531597795, 2531597806, 2531597809, 2531597810, 2531597820, 2531599836, 2531605356, 2531605390; K9306210/2531542260, 2531542263, 2531542270, 2531542292, 2531543553, 2531543568, 2531543588, 2531582676, 2531582691, 2531588558, 2531588562, 2531593741, 2531593749, 2531593752, 2531593763, 2531593764, 2531593768, 2531593777, 2531593784, 2531595829, 2531595831, 2531601786; K9306220/ 2531540107, 2531542441, 2531542470, 2531543538, 2531543549, 2531543611, 2531543613, 2531543640, 2531563132, 2531572740, 2531572759, 2531572770, 2531572814, 2531572827, 2531575652, 2531594331, 2531594332, 2531594336, 2531594348, 2531594350; K9306410/2531572228, 2531582713, 2531582724, 2531582725, 2531584168, 2531584176, 2531584191, 2531588591, 2531588593, 2531588598, 2531588616, 2531588626, 2531604519, 2531604535, 2531604544, 2531604545, 2531604549, 2531604550, 2531604551, 2531604593, 2531604637, 2531604649, 2531604658; K9306420/ 2531537844, 2531537870, 2531537889, 2531537901, 2531537902, 2531556037, 2531556043, 2531572419, 2531572433, 2531572440, 2531595759

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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