Home / Recalls / Medical Devices
NeuroLogica Corporation recalls Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Recalled November 18, 2015 · FDA recall Z-0263-2016 · NeuroLogica
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. · FDA Class II
Units
7 devices
Sold at
Distributed to the states of NC, OH, MA, and MO.
Description
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.
Product
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Manufacturer(s)
NeuroLogica Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →