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Carestream Health, Inc. recalls Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and cont
Recalled January 22, 2020 · FDA recall Z-0806-2020 · Carestream Health
Hazard
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm. · FDA Class II
Units
79
Sold at
Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.
Description
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
Product
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.
Manufacturer(s)
Carestream Health, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →