Z-1172-2021Class II

Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY

Name: Z-1172-2021 Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
Creator: Barco N.V.
Published: 2021-01-22
License: https://open.fda.gov/license/

Barco N.V. / initiated 2021-01-22 / Terminated

FDA source

Barco N.V. began a recall of Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY on 2021-01-22. FDA classified it as Class II and gives the reason as "A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1172-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-22
Posted: 2021-03-04
Terminated: 2022-11-18
Recalling firm: Barco N.V.
Product: Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
Product code: PGY Display, Diagnostic Radiology
Reason for recall: A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.
FDA root cause: Process change control
Action: On January 22, 2021 the firm notified the importer in the USA, Barco Inc.
Quantity in commerce: 1 unit
Distribution: WI.
Product codes and lots: Model Number: MDNC-3421, Serial number 2590263533, UDI/DI 05415334028388.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1172-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1172-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-10	2021-03-04

Product code PGY

K170837Class IINio Color 3MP (MDNC-3421)Barco N.V. / cleared 2017-04-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)