The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning Leksell Gammaknife Perfexion and Icon, manufactured by Elekta Instrument AB.
According to the manufacturer, there is a potentially incorrect mounting of frame adapter to 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.
The manufacturer 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 instructions 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. The manufacturer also reminds users that only trained personnel should be involved in mounting the frame adapter.
A field safety corrective action will be implemented to facilitate a correct mounting of the frame adapter.
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2016-RN-00410-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 April 2016