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
    • 6551360
    • 6551386
    • 6551345
    • 6552160
    • 6552152
    • 6551394
  • DR3500
    • 6553101
    • 6553127
    • 6553119
    • 6553143
    • 6553135
    • 6553036
    • 6553093
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 29, 2020 · Data as of Sep 19, 5:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.