The Recall Desk
ModerateFDA (Devices)·Z-1172-2021·Announced 2021-03-10

Barco Diagnostic Radiology Display Recalled for Lack of DICOM Compliance

Barco N.V. is recalling MDNC-3421 diagnostic radiology displays because they were shipped without being DICOM-compliant. These units will not pass required acceptance tests.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. However, the source text describes a compliance failure (DICOM) rather than a direct physical injury or contamination, aligning with the 'Moderate' criteria for functional defects or voluntary precautionary measures where no immediate physical harm is reported.

Plain-English summary

Barco N.V. is recalling a number of MDNC-3421 diagnostic radiology displays. The recall was initiated because these specific units were shipped while not being DICOM-compliant.

The affected displays are identified by Model Number MDNC-3421, Serial number 2590263533, and UDI/DI 05415334028388. The distribution pattern for this recall is listed as WI. (Wisconsin). The primary issue is that these displays will not pass DICOM acceptance tests, which are standard for diagnostic imaging equipment.

Consumers and healthcare facilities should stop using the affected units and contact Barco N.V. for further instructions on the recall process.

The recalled product

Product
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
Manufacturer
Barco N.V.
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model Number: MDNC-3421
  • Serial number 2590263533
  • UDI/DI 05415334028388.

Distribution

Distributed in 1 state:

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