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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- 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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