Recall Z-1172-2021— Barco N.V.

Name: FDA recall Z-1172-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-22

Class II · Terminated

Class II FDA medical device recall by Barco N.V., initiated 2021-01-22, terminated 2022-11-18. It names one FDA 510(k) clearance: K170837. 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..

Recalling firm: Barco N.V.
Classification: Class II
Status: Terminated
Initiated: 2021-01-22
Terminated: 2022-11-18
Firm location: Kortrijk, Belgium

510(k) clearances named in this recall

1 on FDA's record

K170837 — Nio Color 3MP (MDNC-3421)Barco N.V.·cleared 2017-04-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Barco MDNC-3421 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.