Barco MDSC-8527 NXF, Part Number K9352421 recallZ-0979-2024 · Barco N.V. · initiated Dec 20, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Barco N.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0979-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 20, 2023
- Posted by the FDA
- Feb 2, 2024
- Recalling firm
- Barco N.V.
- Quantity
- 2 units
- Product code
- KQM
- Distribution
- US Nationwide distribution in the state of New Jersey.
Product description
Barco MDSC-8527 NXF, Part Number K9352421
Code information (models, lots, serial numbers)
UDI/DI 05415334043312
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BARCO MDSC-8527Barco NV · Camera, Surgical And Accessories1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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