Summary
The FDA issued a Class II for MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display by Barco N.V.. Reason: 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-6.
Details
Source
Device Recall
External ID
Z-2332-2024
Action Date
2024-07-17
Status
Completed
Category
device
Product Description
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
Lot/Code Info: 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
Quantity Affected: 88 units
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.
Distribution
US: FL
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-24
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 188 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Barco N.V. has 8 FDA actions in our database, including 3 recalls and 5 clearances.
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 N.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Barco N.V. have FDA actions?
Barco N.V. has 8 FDA actions in our database, including 3 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2332-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29