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FDA Medical Device Recalls (openFDA)

Barco N.V.: 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 number
Z-1994-2025
Recalling firm
Barco N.V.
Product
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
Status
Open, Classified
Initiated
2025-05-09
Posted
2025-06-20
Terminated
not on file
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
Root cause
Nonconforming Material/Component
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
Quantity
221
Distribution
US Nationwide distribution in the states of TX, OH.
Lot, serial or model codes
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
510(k) numbers
["K173381"]
PMA numbers
not on file
Product code
DXJ
Firm FEI
3004455125
Firm city
Kortrijk
Firm state
not on file
Firm country
Belgium

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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