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U.S. Department of Health and Human Services

Class 2 Device Recall Barco NV

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 Class 2 Device Recall Barco NVsee related information
Date Initiated by FirmApril 24, 2024
Date PostedJuly 11, 2024
Recall Status1 Completed
Recall NumberZ-2332-2024
Recall Event ID 94731
510(K)NumberK173381 
Product Classification Display, cathode-ray tube, medical - Product Code DXJ
ProductMNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
Code Information serial numbers: 2530986299, 2530986300, 2530986301, 2530986302, 2530986303, 2530986304, 2530986305, 2530986306, 2530986307, 2530986308, 2530986309, 2530986310, 2530986311, 2530986312, 2530986313, 2530986314, 2530986315, 2530986316, 2530986317, 2530986318, 2530986319, 2530986320, 2530986321, 2530986322, 2530986323, 2530986324, 2530986325, 2530986326, 2530986327, 2531041594, 2531041591, 2531041578, 2531041585, 2531041595, 2531041596, 2531041586, 2531041588, 2531041587, 2531041577, 2531041584, 2531041581, 2531041612, 2531041608, 2531041600, 2531041601, 2531041604, 2531041599, 2531041602, 2531041605, 2531041606, 2531041607, 2531041609, 2531041610, 2531041580, 2531041583, 2531041598, 2531041593, 2531041590, 2531041614, 2531041582, 2531041613, 2531041589, 2531041616, 2531041579, 2531041615, 2531041603, 2531041597, 2531041592, 2530985205, 2530986280, 2530986281, 2530986282, 2530986283, 2530986284, 2530986285, 2530986286, 2530986287, 2530986288, 2530986289, 2530986290, 2530986291, 2530986292, 2530986293, 2530986294, 2530986295, 2530986296, 2530986297, 2530986298
Recalling Firm/
Manufacturer		 Barco N.V.
President Kennedypark 35
Kortrijk Belgium
For Additional Information Contact
56-233211
Manufacturer Reason
for Recall		We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDMI or MNA-4x0 ENC HDMI. In some instances, this connection may render the first HDMI channel inaccessible, making both the channel and the respective MNA ENC unit unusable. Additionally, readings from the module become unavailable when this issue arises. Similarly, when this Molex module is connected to the ETH0 slot of an MNA-620 ENC ANA, readings may also become inaccessible.
FDA Determined
Cause 2		Other
ActionBarco NV notified its sole consignee on 04/29/2024 via email. The notice explained the issue, potential risk, and requested the following: "Actions to be taken by the customer: 1. Identify the location and amount of all Molex modules that are listed in pdf document Molex_SN_Partner . 2. Fill out and send back Response Form 1 to your Barco Key Account Manager, including the number of distributed units per country. 3. Disable or discard all used Molex modules. 4. Fill out and send back Response Form 2 to your Barco Key Account Manager after completion of the actions. For question, contact your Barco Key Account Manager.
Quantity in Commerce88 units
DistributionUS: FL
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.
510(K) Database510(K)s with Product Code = DXJ
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