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

Recall date

January 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1391-2018

FDA classification

Class II

Brand / firm

NeuroLogica Corporation

Sold / distributed

US Distribution . Only one consignee was shipped 16 units of the affected device.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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