FDA Device recall Z-1172-2021
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
- FDA Device
- Class II
- terminated
- Published 2021-03-10
On 2021-03-10 the FDA classified a Class II recall of Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY by Barco N V, citing A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1172-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-22 |
| Published | 2021-03-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Barco N V |
| Distribution | WI |
Product
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
Reason
A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.
Identifiers
| code_info | Model Number: MDNC-3421, Serial number 2590263533, UDI/DI 05415334028388. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1172-2021%22
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