FDA recall Z-1172-2021

Barco N.V. · Class II · device

Product

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.

Distribution

WI.

Key facts

Status
Terminated
Initiation date
2021-01-22
Report date
2021-03-10
Termination date
2022-11-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kortrijk, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1172-2021