Class II — Carestream Health, Inc.
| Recalling firm | Carestream Health, Inc. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Quantity | 79 |
| Distribution | Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria. |
| Initiated | 2020-01-06 |
| Classified | 2020-01-13 |
| Terminated | 2020-05-29 |
| Recall number | Z-0806-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Carestream Health, Inc. (Z-0806-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84616/
Alerts for Carestream Health, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.