# FDA recall Z-0806-2020

> **Carestream Health, Inc.** · Class II · device recall initiated 2020-01-06.

## 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.

## Distribution

Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.

## Key facts

- **Recall number:** Z-0806-2020
- **Recalling firm:** Carestream Health, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-06
- **Report date:** 2020-01-22
- **Termination date:** 2020-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0806-2020

## Citation

> AI Analytics. FDA recall Z-0806-2020. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/Z-0806-2020. Source: US FDA. Licensed CC0.

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