Z-1854-2022Class II

Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A

Name: Z-1854-2022 Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
Creator: Barco Nv
Published: 2022-07-27
License: https://open.fda.gov/license/

Barco NV / initiated 2022-07-27 / Open, Classified / root cause: labeling and UDI

FDA source

BARCO NV began a recall of Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A on 2022-07-27. FDA classified it as Class II and gives the reason as "installation issues". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1854-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-27
Posted: 2022-09-29
Recalling firm: Barco NV
Product: Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
Product code: DXJ Display, Cathode-Ray Tube, Medical
Reason for recall: installation issues
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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.
Quantity in commerce: 169 devices
Distribution: US Nationwide distribution in the states of FL, IL, NJ.
Product codes and lots: a) K9303078A, UDI 05415334000056, all serial numbers; b) K9303097A, UDI 05415334001657, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1854-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1854-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-29

Product code DXJ

K173381Class IINexxis ORBarco N.V. / cleared 2018-02-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)