Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: ...
FDA Device Recall #Z-1994-2025 — Class II — May 9, 2025
Recall Summary
| Recall Number | Z-1994-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 9, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Barco N.V. |
| Location | Kortrijk |
| Product Type | Devices |
| Quantity | 221 |
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
Reason for Recall
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
Distribution Pattern
US Nationwide distribution in the states of TX, OH.
Lot / Code Information
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
Other Recalls from Barco N.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2332-2024 | Class II | MNA-420 ENC HDMI, Material Number K9303311; cat... | Apr 24, 2024 |
| Z-0979-2024 | Class II | Barco MDSC-8527 NXF, Part Number K9352421 | Dec 20, 2023 |
| Z-1172-2021 | Class II | Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY | Jan 22, 2021 |
| Z-0527-2019 | Class II | Optional MDRC-1119 Front Cover Attachment Kit ... | Mar 30, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.