| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01480-1 |
| Product Name/Description |
Digital Accelerators with iViewGT or XVI
ARTG number: 111760 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Elekta has identified that if the microswitch in the PCB assembly, solenoid limit switch of the middle arm is not set up correctly, it is possible to get an uncontrolled extension of MV or kV detector arms. It is possible that a collision with the extended arm can cause serious injury. When the detector arm is fully extended there is no risk. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Recommended User Action:
Elekta recommends that the user does not open or close the detector arm when it is positioned above the patient, as specified in the Instructions for use (IFU).
iViewGT
Elekta recommends that the detector panel is not opened or closed when the gantry is at 180° (±45°), especially when a patient is on the treatment table.
The movement of the MV detector panel at these angles can disturb a patient if they are below the detector panel.
XVI
Elekta recommends that you do not open or close the detector arms when they are in a position above the patient.
Distribute the supplied notice to all users of the system at your facility. Include a copy of the supplied notice with the system manuals.
To acknowledge the receipt of this letter please complete the Confirmation of receipt form you receive from Elekta's automated distribution system.
Return the form even if you no longer have the affected units at your site.
This action has been closed out on the 06/12/2018. |
| Contact Information |
02 89071800 - Elekta Customer Support |