Reported Jan 22, 2020 · Terminated
Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and…
Carestream Health, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carestream Health, Inc. · 1049 W Ridge Rd · Rochester, NY · 14615-2731
Is this the product you have?
- Kodak
- DirectView DR3000/3500 - Product Usagepermanently 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
- Lot codes and dates
- DR3000
655136065513866551345655216065521526551394
- DR3500
6553101655312765531196553143655313565530366553093
- DR3000
- Amount recalled
- 79
Where it was sold
Why it was recalled
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
This product could cause temporary or reversible health problems — stop using it.
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