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