Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
Summary
The FDA issued a Class II for Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbe by BARCO NV. Reason: installation issues.
Details
Source
Device Recall
External ID
Z-1854-2022
Action Date
2022-10-05
Status
Ongoing
Category
device
Product Description
Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
Lot/Code Info: a) K9303078A, UDI 05415334000056, all serial numbers; b) K9303097A, UDI 05415334001657, all serial numbers
Quantity Affected: 169 devices
Reason for Recall
installation issues
Distribution
US Nationwide distribution in the states of FL, IL, NJ.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-27
Company
Kortrijk, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BARCO NV) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BARCO NV have FDA actions?
This is the only FDA action we have on record for BARCO NV in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1854-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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