تسجيل الدخول
تسجيل جديد
الخميس - رمضان 13, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-02-02-25-771
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
TBS iNsight
الأجهزة المتأثرة
UDI: +B214OSTBSI3120, +B214OSTBSI3110, +B214OSTBSIV310, +B214OSTBSIV300 Device Model: TBS iNsight v3.x / pn: OS-TBSi Software version: V3.x
الممثل المعتمد
Bio Standards LLC
سبب المشكلة
A potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
الإجراء التصحيحي
Please follow the below patient management recommendations: To reduce variability in calculations from fast array scans on Hologic Horizon machines and mitigate the newly identified risk, clinicians are advised to consider using the standard array mode for TBS calculations, where feasible, until the update becomes available. The forthcoming software maintenance release will incorporate an enhanced correction factor for fast array scans, ensuring a more tailored correction between the two scan modes and greater accuracy across the BMI range. Medimaps will issue a maintenance release of the software. Manufacturer action: Instructions and correction.
المرفقات
عودة للقائمة
