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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 Elekta Pty Ltd
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