Z-0263-2016 Class II Terminated
FDA device recall Z-0263-2016 was initiated by NeuroLogica Corporation on September 14, 2015 and is designated Class II. 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 … The recall status is terminated (terminated January 19, 2017). Affected quantity: 7 devices.
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