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.
Reported: January 22, 2020 Initiated: January 6, 2020 #Z-0806-2020
Product Description
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.
Details
- Recalling Firm
- Carestream Health, Inc.
- Units Affected
- 79
- Distribution
- Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Carestream Health, Inc.. Units affected: 79.
Why was this product recalled? ▼
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2020. Severity: Moderate. Recall number: Z-0806-2020.
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