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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-23-01-25-761
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Alinity m system
الأجهزة المتأثرة
List Number: 08N53 Refer to Appendix A in the attachment for more details.
الممثل المعتمد
Medical Supplies and Services Co Ltd
سبب المشكلة
It has been identified by Abbott that an Integrated Reaction Unit (IRU) Elevator panel is missing on certain Alinity m Systems due to an assembly error.
الإجراء التصحيحي
The local representative will contact customers to schedule an instrument inspection. If the elevator panel is missing, it will be installed. Customers are advised to follow instructions in applicable sections of the Alinity m Operations Manual. Specifically, to reduce the risk of mechanical hazards, they should not perform manual tasks on the system's work surface and should not insert any part of the body into an area of mechanical movement during system operation. Manufacturer action: Instructions and correction.
المرفقات
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