Reported May 13, 2015 · Terminated

EOS, Digital radiography system used in general radiographic examinations.

Eos Imaging 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: Eos Imaging Inc · 185 Alewife Brook Pkwy Ste 410 · Cambridge, MA · 02138-1104

Is this the product you have?

  • EOS, Digital radiography system used in general radiographic examinations.
Lot codes and dates
  • Model Number - EOS System
Amount recalled
13 units installed in US

Where it was sold

Why it was recalled

When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.

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 31, 2017 · Data as of Sep 19, 5:31 PM UTC

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