| 2020-12-08 |
Class II
|
Terminated |
Z-0869-2021 |
Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating an… |
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A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the ta… |
| 2020-06-23 |
Class II
|
Terminated |
Z-2884-2020 |
Neurosign V4 Intraoperative Nerve monitor family of devices. |
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Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator p… |
| 2020-03-23 |
Class II
|
Terminated |
Z-1966-2020 |
Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adu… |
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It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to f… |
| 2020-03-23 |
Class II
|
Terminated |
Z-1965-2020 |
Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disor… |
— |
It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to f… |