FDA Medical Device Recalls (openFDA)
Barco N.V.: Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
- Recall number
- Z-1172-2021
- Recalling firm
- Barco N.V.
- Product
- Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
- Status
- Terminated
- Initiated
- 2021-01-22
- Posted
- not on file
- Terminated
- 2022-11-18
- Reason
- A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.
- Root cause
- Process change control
- Action
- On January 22, 2021 the firm notified the importer in the USA, Barco Inc.
- Quantity
- 1 unit
- Distribution
- WI.
- Lot, serial or model codes
- Model Number: MDNC-3421, Serial number 2590263533, UDI/DI 05415334028388.
- 510(k) numbers
- ["K170837"]
- PMA numbers
- not on file
- Product code
- PGY
- Firm FEI
- 3004455125
- Firm city
- Kortrijk
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28