Reported Dec 24, 2014 · Terminated

CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of…

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?

  • CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Lot codes and dates
  • Software Verions
    • 1) 5.7.312.27
    • 2) 5.7.312.27
    • 3) 5.7.312.2031
Amount recalled
59 units

Where it was sold

Why it was recalled

Reduced mammographic image quality when attempting to print true size multi-format images

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 Mar 10, 2017 · Data as of Sep 19, 5:25 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.