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مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-15-12-25-1184
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اسم الجهاز الطبي
Leksell GammaPlan
الأجهزة المتأثرة
Leksell GammaPlan® versions 11.1, 11.3 and 11.4 in use with Leksell Gamma Knife® Icon and Leksell Gamma Knife® Elekta Esprit. UDI Reference: 07340048311236, 07340048311878, 07340201502136.
الممثل المعتمد
Medical Regulations Gate
سبب المشكلة
Defining a new stereotactic reference in an examination for a frame treatment while failing to first change an already defined obsolete stereotactic reference (representing a non-current frame fitting) to a pre-plan reference, may result in a treatment plan that irradiates the wrong patient location if the resulting inconsistent alignment between the stereotactic references is not detected by the user.
الإجراء التصحيحي
If the stereotactic reference for a frame treatment must be changed prior to plan approval (e.g. due to a change of frame fitting), make sure to first change the already defined obsolete stereotactic reference to a pre-plan reference before defining the new stereotactic reference. By so doing, the treatment examination is automatically updated according to the new stereotactic reference when it is defined. Do not combine the use of a stereotactic CBCT reference with other stereotactic references for treatments with a frame. This specific recommendation for CBCT is motivated by the increased likelihood of failure for users to detect an inconsistent stereotactic CBCT reference relative to other stereotactic references, compared to MR and CT image studies, which are typically displayed and explored throughout the planning process. Manufacturer Action: Correction.
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