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Terminated

Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY

FDA Recall Z-1172-2021 · Posted None

Recalling FirmBarco N.V.
Recall StatusTerminated
Product CodePGY
Date Initiated2021-01-22
Date Terminated2022-11-18
Product Quantity1 unit

Reason for Recall

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

Firm Action

On January 22, 2021 the firm notified the importer in the USA, Barco Inc.

Root Cause

Process change control

Distribution Pattern

WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170837Nio Color 3MP (MDNC-3421)Barco N.V. · 2017-04-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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