Carestream Health, Inc. recalls Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and con…

Recall date

January 6, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0806-2020

FDA classification

Class II

Brand / firm

Carestream Health, Inc.

Sold / distributed

Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 controls for the collimator shutter are accomplished at the operator console.