FDAClass IIMarch 10, 2021

Barco Mdnc-3421 Display recall

Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY

Why was Barco Mdnc-3421 Display recalled?

A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
Recalling firm
Barco N.V.
Quantity
1 unit
Distribution
WI.
Recall date
March 10, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls