Z-1172-2021 Class II Terminated
FDA device recall Z-1172-2021 was initiated by Barco N.V. on January 22, 2021 and is designated Class II. Reason for recall: A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests. The recall status is terminated (terminated November 18, 2022). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- March 10, 2021
- Initiation Date
- January 22, 2021
- Termination Date
- November 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
Distribution Pattern
WI.
Code Information
Model Number: MDNC-3421, Serial number 2590263533, UDI/DI 05415334028388.