NeuroLogica Corporation recalls Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human ana…

Recall date

May 24, 2017

Source

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

Recall number

Z-3036-2017

FDA classification

Class II

Brand / firm

NeuroLogica Corporation

Sold / distributed

Nationwide Distribution

Why it was recalled

When performing the Stitching function on GU60A system, unintended area is exposed to radiation

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

What was recalled

Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications