تسجيل الدخول
تسجيل جديد
السبت - جمادى الآخرة 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-23-10-25-1106
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Multiva 1.5T MR Systems
الأجهزة المتأثرة
Product Number (Device Identifier): 781072 ((01)00884838073890) 781073 ((01)00884838073883) 781074 ((01)00884838073906) 781076 (N/A) 781078 ((01)00884838047631)
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd
سبب المشكلة
The Quadrature Body Coil (QBC) seal adhesive may fail creating sharp edges that may come in contact with patients.
الإجراء التصحيحي
Philips instructs the customer / user to take these actions in order to prevent risks for patients or users: • As part of the preparation before a patient scan: 1. Inspect the QBC seal for separation between the cone cover and QBC cover. 2. If QBC seal is found detached or loose, Stop-use immediately. 3. Contact your local Philips service representative. • If QBC seal becomes loose during a patient scan: 1. Immediately stop scanning and carefully remove patient from the system. 2. Contact your local Philips service representative. Philips will contact the affected customers to schedule a time for a Field Service Engineer (FSE) to visit their site to inspect their system’s QBC Seal and replace the QBC Seal if necessary. Manufacturer's Action: Instructions and Correction.
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