| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00410-1 |
| Product Name/Description |
Leksell Gammaknife Perfexion and Leksell Gammaknife Icon
(used for stereotactic irradiation of head structures)
ARTG Number: 182102 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential for incorrect mounting of the frame adapter to the coordinate frame. The latches of the frame adapter can be locked even if the locating pins of the frame adapter are not inserted into the corresponding holes in the coordinate frame. If the frame adapter is mounted incorrectly to the coordinate frame and this is not noticed by the user before treatment is started, dose will be delivered in the wrong place by up to 2cm. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is advising users that the frame adapter is safe to use provided that the Instructions for use are followed and conducted by a trained professional. It is of the highest importance that the frame adapter is mounted to the coordinate frame as described in the applicable Instruction for Use. The locating pins of the frame adapter shall be inserted into the corresponding holes in the coordinate frame before the three latches are locked. Also make sure that only trained personnel are involved in mounting the frame adapter. A field corrective action will be implemented to facilitate a correct mounting of the frame adapter.
This action has been closed out on the 14/09/2018. |
| Contact Information |
02 8907 1800 - Elekta |