| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01107-1 |
| Product Name/Description |
Leksell Gamma Knife Perfexion (teletherapy device indicated for stereotactic irradiation of head structures)
Frame Adapter Serial Numbers: FV001 to FV376
ARTG Number: 182102 & 182943 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
In Leksell Gamma Knife Perfexion, the coordinate frame is fixed to the Patient Positioning System before treatment using a frame adapter. The coordinate frame is locked to the frame adapter via latches. The latches shall be turned ninety degrees and then locked. The manufacturer has got a report that the latches may be locked before they have been fully turned resulting in a poorly locked frame. Investigations show that it may be possible to have a situation where the adapter latches can get stuck just above the coordinate frame surface and as a result the coordinate frame will not be fixed properly. If the coordinate frame is not correctly locked to the frame adapter a play may occur and possibly move the target from planned position by up to 0.5 mm. There is a potential of mistreatment due to the patient being incorrectly positioned. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta has initiated more stringent measurements in manufacturing and will check/replace affected frame adapters in the field. Meanwhile, the users are advised the following:
- Always assure that the plastic lever is only operated when at a right angle with the frame adapter.
- Do not force the plastic lever in place if it meets significant resistance when turned.
- Ensure that the plastic lever is completely flush with the frame adapter and that no angulations are present. This action has been closed-out on 06/09/2016. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |