FDAJanuary 6, 2020device

Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky assembly and control...

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

The hazard

Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.

What to do

FDA enforcement status: Terminated

Brands named

carestream healthcarestream

Recall history

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

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