FDAMay 5, 2021device

Omnera 400T Digital Radiographic System

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).

What to do

FDA enforcement status: Ongoing

Brands named

arcoma abarcoma

UPCs

07350008750050

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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