Leksell Gamma Knife Perfexion (teletherapy device indicated for stereotactic irradiation of head structures) 의 리콜

Recall

RC-2014-RN-01107-1

Class I

2014-10-14

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01107-1

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.

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.