FDA Recall
Terminated
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
Recall: Z-1172-2021
·
Initiated January 22, 2021
Recall
- Recall Number
- Z-1172-2021
- Event Number
- 87288
- Firm
- Barco N.V. President Kennedypark 35 Kortrijk Belgium
- FEI Number
- 3004455125
- Product Code
- PGY
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- January 22, 2021
- Terminated
- November 18, 2022
Description
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.
Action
On January 22, 2021 the firm notified the importer in the USA, Barco Inc.
Distribution
WI.
Quantity
1 unit