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تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
تواصل معنا
EN
SA-04-11-24-658
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Philips MR system breast coils
الأجهزة المتأثرة
Please refer to the attachment for the affected products names and numbers.
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd
سبب المشكلة
It has been identified an issue with patient set up while using the MR system breast coil where, if the cross-section of the prone patient, breast coil, and patient table exceeds the internal diameter of the magnet bore, the patient may be compressed between the breast coil and top of the magnet bore potentially resulting in harm to the patient. Additionally, in cases of compromised bone strength, the pressure points created between the prone patient and the breast coil could be exaggerated due to exam duration, the machines vibrations and/or patient positioning that induces pain, resulting in harm to the patient.
الإجراء التصحيحي
Please refer to the attachment which contains recommendations for continued use of the systems (Actions that should be taken by the customer / user in order to prevent risks for patients). Manufacturer Action: Instructions.
المرفقات
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