تسجيل الدخول
تسجيل جديد
السبت - جمادى الآخرة 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-06-06-24-446
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
SENSE XL Torso (1.5T and 3.0T) Coils
الأجهزة المتأثرة
Models: 45356714188x, 45356750228x, 45980158521x, 45356739494x, 45980159318x All serial numbers of all iterations of the models above.
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd.
سبب المشكلة
It has been identified an issue in the SENSE XL Torso (1.5T and 3.0T) coils which may result in localized heating during the scan, resulting in potential harm to patients.
الإجراء التصحيحي
Please refer to the attachment for details (Actions that should be taken by the customer / user). ----- October 2025 update: Philips will contact you to schedule time for a Field Service Engineer (FSE) to visit your site to upgrade the SW as they are released. (Ref FCOs below): • Instruction For Use (IFU) Update: Including additional warnings and illustrations. • User interface: Updated with additional information and workflow support (cool-down periods) to enable safe usage of the coil during an examination. Manufacturer Action: Instructions and Correction.
المرفقات
عودة للقائمة
