Reported Mar 14, 2018 · Terminated

The GC80 Digital X-ray Imaging System

NeuroLogica Corporation

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: NeuroLogica Corporation · 14 Electronics Ave · Danvers, MA · 01923-1011

Is this the product you have?

  • The GC80 Digital X-ray Imaging System
Lot codes and dates
  • Accession Number 1310459
Amount recalled
45 units

Where it was sold

  • Nationwide

Why it was recalled

An image was obtained with over exposure during a Thorax examination using the AEC function.

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 Oct 5, 2018 · Data as of Sep 19, 5:22 PM UTC

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