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U.S. Department of Health and Human Services

Class 2 Device Recall Barco

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 Class 2 Device Recall Barcosee related information
Date Initiated by FirmJuly 27, 2022
Date PostedSeptember 29, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1854-2022
Recall Event ID 90807
510(K)NumberK173381 
Product Classification Display, cathode-ray tube, medical - Product Code DXJ
ProductBarco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
Code Information a) K9303078A, UDI 05415334000056, all serial numbers; b) K9303097A, UDI 05415334001657, all serial numbers
Recalling Firm/
Manufacturer		 BARCO NV
Beneluxpark 8500
Kortrijk Bulgaria
Manufacturer Reason
for Recall		installation issues
FDA Determined
Cause 2		Labeling design
ActionBarco 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 Commerce169 devices
DistributionUS Nationwide distribution in the states of FL, IL, NJ.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DXJ
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