FDA Medical Device Recalls (openFDA)
Barco N.V.: Barco MDSC-8527 NXF, Part Number K9352421
- Recall number
- Z-0979-2024
- Recalling firm
- Barco N.V.
- Product
- Barco MDSC-8527 NXF, Part Number K9352421
- Status
- Open, Classified
- Initiated
- 2023-12-20
- Posted
- 2024-02-02
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- Barco 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
- 2 units
- Distribution
- US Nationwide distribution in the state of New Jersey.
- Lot, serial or model codes
- UDI/DI 05415334043312
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KQM
- Firm FEI
- 3004455125
- Firm city
- Kortrijk
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28