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الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
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EN
SA-02-10-25-1076
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Digital Diagnostic Mobile X-ray System GM85
الأجهزة المتأثرة
Model: GM85 (Digital Mobile X-ray System) Scope: Systems manufactured between October 2016 and July 2018. Unique Device Identifier (UDI-DI): [8806090DGRGM001XK]
الممثل المعتمد
Attieh Medico Ltd
سبب المشكلة
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue. This can lead to instability or wobbling of the arm. In a worst-case scenario where all bolts fail, the Tube Head Unit could detach.
الإجراء التصحيحي
You may continue to use the system. If any issues with the bolts are detected, then please contact the service engineer immediately for inspection. Please read and follow the instructions in the attachment. Samsung service engineers will contact you to arrange for the correction to reinforce the arm with a high tensile bolt to eliminate the risk of the THU falling and preventing any potential risk of injury. Manufacturer's Action: Instructions and Correction.
المرفقات
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