| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01256-1 |
| Product Name/Description |
AIRO Mobile CT Scanner
Model: MobiCT-32
Serial Numbers: AIRO-0162, AIRO-0143, AIRO-0154, AIRO-0146, AIRO-0149, AIRO-0209 and AIRO-0217
ARTG Number: 223542 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Mobius Imaging, believes that due to an issue with the configuration settings of the tilt-drive motion controller, if a tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended tilt motion of gantry while AIRO system is homing the axis at startup or preparing for a scan. Since the AIRO is not currently monitoring for intermittent connections or broken tilt-drive motor wires, if a wire breaks or the signal becomes intermittent the tilt-drive motor would not get the correct feedback and the motor could behave unpredictably.
The following behaviours could be seen in the AIRO:
When pushing the green button to home/tilt the gantry, the gantry may tilt in either direction, and at a higher than normal speed. The operator may not be able to respond (by releasing green button or pressing the Emergency Stop Button) in time to prevent harm.
To date, there have been no injuries reported related to this issue |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Due to the risk of unintended (tilting) motion of the gantry, customers are advised to discontinue using the AIRO until the tilt drive motion firmware has been updated on their system. Brainlab is arranging the firmware update for installation on the affected serial numbers on 29 September 2017.
This action has been closed out on 15/10/2018 |
| Contact Information |
02 9424 3800 - Brainlab |