Reported Oct 10, 2012 · Terminated

EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.

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 X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
Lot codes and dates
  • All associated Serial Numbers
Amount recalled
12 EOS Systems installed in the US

Where it was sold

  • Nationwide

Why it was recalled

It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode.

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 Sep 16, 2013 · Data as of Sep 19, 5:24 PM UTC

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