Z-0263-2016 Class II Terminated

Recalled by NeuroLogica Corporation — Danvers, MA

Recall Details

Product Type
Devices
Report Date
November 18, 2015
Initiation Date
September 14, 2015
Termination Date
January 19, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7 devices

Product Description

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

Reason for Recall

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.

Distribution Pattern

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

Code Information

Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E, 50EAM9BG200007F