Medical Device
Manufacturing
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Z-2332-2024Class II

MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display

Barco N.V. / initiated 2024-04-24 / Completed

Barco N.V. began a recall of MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Completed.

Recall record

Recall number
Z-2332-2024
Classification
Class II
Status
Completed
Initiated
Posted
Recalling firm
Barco N.V.
Product
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
Product code
DXJ Display, Cathode-Ray Tube, Medical
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 root cause
Other
Action
Barco 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 commerce
88 units
Distribution
US: FL
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2332-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2332-2024Class IICompletedVoluntary: Firm initiated