FDA-Device2015-11-18Class II

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

NeuroLogica Corporation
Hazard

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.

Sold states
Distributed to the states of NC, OH, MA, and MO.
Affected count
7 devices
Manufactured in
14 Electronics Ave, N/A, Danvers, MA, United States
Products
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0263-2016

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