Z-0979-2024Class II

Barco MDSC-8527 NXF, Part Number K9352421

Name: Z-0979-2024 Barco MDSC-8527 NXF, Part Number K9352421
Creator: Barco N.V.
Published: 2023-12-20
License: https://open.fda.gov/license/

Barco N.V. / initiated 2023-12-20 / Open, Classified / root cause: manufacturing process

FDA source

Barco N.V. began a recall of Barco MDSC-8527 NXF, Part Number K9352421 on 2023-12-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0979-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-20
Posted: 2024-02-02
Recalling firm: Barco N.V.
Product: Barco MDSC-8527 NXF, Part Number K9352421
Product code: KQM Camera, Surgical And Accessories
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 2 units
Distribution: US Nationwide distribution in the state of New Jersey.
Product codes and lots: UDI/DI 05415334043312

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0979-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0979-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-02

Product code KQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)