Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
- Company
- Neurologica Corporation
- Recall Initiated
- September 14, 2015
- Posted
- November 10, 2015
- Terminated
- January 19, 2017
- Recall Number
- Z-0263-2016
- Quantity
- 7 devices
- Firm Location
- Danvers, MA
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
Distributed to the states of NC, OH, MA, and MO.
Lot / Code Info
Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E, 50EAM9BG200007F
Root Cause
Device Design
Action Taken
An Urgent - Field Safety Notice identifying the affected products, problem involved, root cause, and potential hazards, was sent to customers. In the event the issue occurs, users can release the drive handle or press the emergency switch and the unit will stop. Then, reboot the system. If unintended movements occur, please contact local representative. To correct the issue, service engineers will visit to apply the corrective action. For further information or support concerning this problem, contact local representative.