FDA Device recall Z-0806-2020
Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for exam…
- FDA Device
- Class II
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class II recall of Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for exam… by Carestream Health, citing carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0806-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-06 |
| Published | 2020-01-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Carestream Health |
| Distribution | IA |
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
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
Identifiers
| code_info | DR3000: 6551360, 6551386, 6551345, 6552160, 6552152, 6551394 DR3500: 6553101, 6553127, 6553119, 6553143, 6553135, 6553036, 6553093 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0806-2020%22
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