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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 FirmDecember 20, 2023
Date PostedFebruary 02, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0979-2024
Recall Event ID 93712
Product Classification Camera, surgical and accessories - Product Code KQM
ProductBarco MDSC-8527 NXF, Part Number K9352421
Code Information UDI/DI 05415334043312
FEI Number 3004455125
Recalling Firm/
Manufacturer		 Barco N.V.
President Kennedypark 35
Kortrijk Belgium
For Additional Information ContactMs Inge Govaerts
56-233211
Manufacturer Reason
for Recall		Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MNA decoder is blocked.
FDA Determined
Cause 2		Under Investigation by firm
ActionBarco sent an email to their sole consignee on 12/14/2023 regarding the issue with the device and followed with a Customer Notice issued on 12/20/2023, also by email. The notice explained the issue, potential risk, and requested the following actions: A) Assess & locate the affected units and block them for further distribution. Please identify affected devices and find out where they are. These units should not be further processed within the distribution chain. B) Return the units to Barco Please return the products to Barco using the RMA form received by Barco. This form will be communicated in the next day. Please provide pick up details accordingly. C) Return Acknowledgement Letter to Barco upon completion of the actions. Please complete the Acknowledgement Letter provided in this document and send it back to your Barco contact after you have completed the actions described in this letter. The consignee was directed to ensure that your customers and users who have received affected products, are made aware of this notification and of the recommended actions and that you are the primary contact for them concerning this issue. Please provide each of your customers or users with a copy of this notice.
Quantity in Commerce2 units
DistributionUS Nationwide distribution in the state of New Jersey.
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.
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