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