Guest guest Posted November 10, 1999 Report Share Posted November 10, 1999 Look under www.fda.gov click on search and type in Gamma knife Click on enforcement reports Nov 11 Use the edit find function in your browser to find the word " gamma " or just scroll down( it's a very big file). The first few pages are food recalls. Medical device reports are about two thirds the way down. There are several Gamma Knife software problems resulting in over or under dosing patients. PRODUCT Leksell GammaPlan (LGP) Version 4.01-4.11, software is designed for use with the Leksell Gamma> <Knife>. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. Recall #Z-118-9. REASON An error in the plug command which caused the dose planning software GammaPlan to give too long treatment times, meaning that the patient receives a higher dose than prescribed. --------------------------------------------- PRODUCT Quote Link to comment Share on other sites More sharing options...
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