Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY recallZ-1172-2021 · Barco N.V. · initiated Jan 22, 2021
Terminated
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
A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.
FDA root cause category: Process change control
What the company is doing
On January 22, 2021 the firm notified the importer in the USA, Barco Inc.
Recall details
- Recall number
- Z-1172-2021
- Status
- Terminated
- Initiated by the company
- Jan 22, 2021
- Recalling firm
- Barco N.V.
- Quantity
- 1 unit
- Product code
- PGY
- FDA submissions
- K170837
- Distribution
- WI.
Product description
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
Code information (models, lots, serial numbers)
Model Number: MDNC-3421, Serial number 2590263533, UDI/DI 05415334028388.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Nio Color 3MP MDNC-3421Barco NV · Display, diagnostic radiology1 recall0 reports
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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