| 2021-07-29 |
Class II
|
Terminated |
Z-2339-2021 |
OASIS MRI System |
— |
There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of F… |
| 2021-07-29 |
Class II
|
Terminated |
Z-2338-2021 |
ECHELON Oval MRI System |
— |
There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of F… |
| 2021-07-29 |
Class II
|
Terminated |
Z-2337-2021 |
ECHELON MRI System |
— |
There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of F… |
| 2021-06-30 |
Class II
|
Ongoing |
Z-2308-2021 |
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and… |
— |
The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe… |