CLASS II Device recall · Reported 22 Jan 2020 · FDA Enforcement Report
Kodak DirectView DR3000/3500 recalled by Carestream Health
Carestream Health is recalling Kodak DirectView DR3000/3500, distributed in Iowa. The recall was initiated on 6 Jan 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0806-2020
- FDA event ID
- 84616
- Recalling firm
- Carestream Health, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jan 2020
- FDA classified
- 13 Jan 2020
- Reported
- 22 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 6 Jan 2020 | Recall initiated by company | |
| 13 Jan 2020 | Classified by FDA | +7 days |
| 22 Jan 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.
Questions about this recall
Why was it recalled?
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
Which lots are affected?
DR3000: 6551360, 6551386, 6551345, 6552160, 6552152, 6551394 DR3500: 6553101, 6553127, 6553119, 6553143, 6553135, 6553036, 6553093
Where was it sold?
Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Carestream Health
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DRX Revolution Mobile X-Ray System recalled by Carestream Health | Carestream Health | Device Malfunction | Nationwide |
| Device | CLASS II | The DRX-Revolution Mobile X-Ray System is a diagnostic recalled | Carestream Health | Device Malfunction | Nationwide |
| Device | CLASS II | Drx-Compass/Dr-fit X-ray Systems with Firmware recalled | Carestream Health | Other | Nationwide |
| Device | CLASS II | OnSight 3D Extremity System- X-Ray, Tomography Computed System recalled | Carestream Health | Other | Nationwide |
| Device | CLASS II | DRX-Revolution Mobile X-Ray System recalled by Carestream Health | Carestream Health | Other | Nationwide |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |