Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331
Medical device recall Z-1994-2025. Published in FDA’s Enforcement Report on Jul 2, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 2, 2025. Copied from openFDA on Nov 4, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 3 states named
- 223 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Which ones are recalled?
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
223, in FDA’s words.
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Codes to check against yours
REF/UDI-DI/Serial Number: K9303320/05415334002364/2531531598, 2531531604, 2531534397, 2531534420, 2531534430, 2531534466, 2531534905, 2531534948, 2531534956, 2531536564, 2531554560, 2531572616, 2531572628, 2531572634, 2531591962,…
Every code shown here, 1,991 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, 2530887517, 2530887515; 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,…
FDA’s list runs to 2,834 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution in the states of TX, OH. NJ.
The states and territories these words name
- New Jersey
- Ohio
- Texas
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 9, 2025.
- FDA classified it on Jun 20, 2025.
- FDA’s Enforcement Report published it on Jul 2, 2025.
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Who is recalling it?
- Barco N.V., of Kortrijk, Belgium.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,834 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Nov 3, 2026 and checked Nov 4, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Nov 4, 2026.