NeuroLogica Corporation recalls Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.

Recall date

September 14, 2015

Source

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

Recall number

Z-0263-2016

FDA classification

Class II

Brand / firm

NeuroLogica Corporation

Sold / distributed

Distributed to the states of NC, OH, MA, and MO.

Why it was recalled

When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted.

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 GM60A-40S Intended for use in generating radiographic images of human anatomy.