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تسجيل جديد
الخميس - رجب 5, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
تواصل معنا
EN
SA-23-12-25-1193
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Axios Stent and Electrocautery Enhanced Delivery System
الأجهزة المتأثرة
Please refer to the attachment.
الممثل المعتمد
Boston Scientific Gulf for trading LLC
سبب المشكلة
An increased reports of stent deployment and expansion issues in the affected products.
الإجراء التصحيحي
1- Please immediately discontinue use of the Boston Scientific product reported in the list and remove all of the affected units from your inventory, regardless of where these units are stored in your facility. Segregate the units in a secure place, pending return to Boston Scientific. 2- Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. 3- Please complete the attached Verification Form even if you do not have any product to return. 4- If you have products to return, please package them in an appropriate shipping box. Manufacturer Action: Removal
المرفقات
عودة للقائمة
