CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
Barco Mdsc-8527 NXF recalled by Barco N.V
Barco N.V is recalling Barco Mdsc-8527 NXF, distributed nationwide in the US. The recall was initiated on 20 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0979-2024
- FDA event ID
- 93712
- Recalling firm
- Barco N.V, Kortrijk
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Dec 2023
- FDA classified
- 2 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Dec 2023 | Recall initiated by company | |
| 2 Feb 2024 | Classified by FDA | +44 days |
| 14 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Barco MDSC-8527 NXF, Part Number K9352421
Where it was distributed
US Nationwide distribution in the state of New Jersey.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI/DI 05415334043312
Where was it sold?
US Nationwide distribution in the state of New Jersey.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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