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Recall Observatory FDA recall evidence

Device product

Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY

Z-1172-2021

January 22, 2021

Class II

Product summary

Firm
Barco N.V.
Event
Event 87288
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1172-2021

Official wording

Reason: A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.

Code information: Model Number: MDNC-3421, Serial number 2590263533, UDI/DI 05415334028388.

Distribution pattern: WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.