Recall Z-0263-2016 ยท IZI System, X-Ray, Angiographic
NeuroLogica Corporation
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
| Date | Nov 10, 2015 (initiated Sep 14, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 7 devices |
| Distribution | Distributed to the states of NC, OH, MA, and MO. |
| FDA record | Open on fda.gov |