Recall Z-0263-2016
NeuroLogica Corporation · initiated September 14, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Codes / lots: Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E, 50EAM9BG200007F
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.
FDA-determined 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.
Details
- Recall number
- Z-0263-2016
- Initiated
- September 14, 2015
- Posted by FDA
- November 10, 2015
- Terminated
- January 19, 2017
- Product code
- IZI – System, X-Ray, Angiographic
- Quantity
- 7 devices
- Distribution
- Distributed to the states of NC, OH, MA, and MO.
- Recalling firm
- NeuroLogica Corporation, Danvers, MA