Kodak DirectView DR3000/3500 — Class II medical device recall Z-0806-2020
Terminated recall by Carestream Health, Inc., reported 2020-01-22, distributed in IA. Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
| Recall number | Z-0806-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health, Inc., Rochester, NY, United States |
| Recall initiated | 2020-01-06 |
| Classified | 2020-01-13 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2020-05-29 |
| Distributed | IA |
| Countries outside the US | AT, CN, ES, IT |
| Quantity | 79 |
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.
Reason for recall
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0806-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.