Nexxis recallZ-1854-2022 · Barco NV · initiated Jul 27, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Barco NV or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
installation issues
FDA root cause category: Labeling design
What the company is doing
Barco NV began notifying its consignees on about August 29, 2022, via email, about the device malfunction and stated that they would be providing an updated instructions for use (IFU). The firm followed with a Field Safety Action, via email on the same day, which described the issue, potential risks and a copy of the updated IFU. The letter requested the following: 1. Fill out and send back Response Form 1 to Barco Key Account Manager after receipt of this Notice. 2. Read the updated installation instructions, including the potential risk of wrong installation. 3. Inform relevant partners and ask them to evaluate if their installations must be adapted. 4. Fill out and send back Response Form 2 to Barco Key Account Manager after completion of the actions.
Recall details
- Recall number
- Z-1854-2022
- Status
- Open, Classified
- Initiated by the company
- Jul 27, 2022
- Posted by the FDA
- Sep 29, 2022
- Recalling firm
- Barco NV
- Quantity
- 169 devices
- Product code
- DXJ
- FDA submissions
- K173381
- Distribution
- US Nationwide distribution in the states of FL, IL, NJ.
Product description
Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
Code information (models, lots, serial numbers)
a) K9303078A, UDI 05415334000056, all serial numbers; b) K9303097A, UDI 05415334001657, all serial numbers
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Nexxis MNA-240Barco NV · DISPLAY, CATHODE-RAY TUBE, MEDICAL1 recall0 reports
- Nexxis MNA-240Barco NV · DISPLAY, CATHODE-RAY TUBE, MEDICAL1 recall0 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K173381 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Nexxis MNA-440Barco NV · DISPLAY, CATHODE-RAY TUBE, MEDICAL1 recall0 reports
- Nexxis MNA-420Barco NV · DISPLAY, CATHODE-RAY TUBE, MEDICAL1 recall0 reports
- Nexxis OR MNA-440 DECBarco NV · DISPLAY, CATHODE-RAY TUBE, MEDICAL1 recall0 reports
- Nexxis OR MNA-420 DECBarco NV · DISPLAY, CATHODE-RAY TUBE, MEDICAL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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