NeuroLogica Corporation recalls Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for u…

Recall date

May 6, 2019

Source

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

Recall number

Z-1691-2019

FDA classification

Class II

Brand / firm

NeuroLogica Corporation

Sold / distributed

US Nationwide Distribution

Why it was recalled

Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.

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 GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is 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