FDA Medical devices recall ·
Model: Description recall
- Recall number
- Z-1994-2025
- Date
- (initiated May 9, 2025)
- Company / brand
- Barco N.V.
President Kennedypark 35, Kortrijk, Belgium - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 221
- Hazard tags
- Fall
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide distribution in the states of TX, OH.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1994-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.