FDA-Device2020-01-22Class II
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.
Carestream Health, Inc.
Hazard
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
Sold states
Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.
Affected count
79
Manufactured in
1049 W Ridge Rd, Rochester, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0806-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief