Reported Apr 25, 2018 · Terminated

Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical

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?

  • Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
Lot codes and dates
  • Model Number GMR40. Serial numbers 00001 through 00016.
Amount recalled
16 units

Why it was recalled

While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.

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 Aug 14, 2018 · Data as of Sep 19, 6:07 PM UTC

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