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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-03-02-25-773
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Artis one/ARTIS one systems
الأجهزة المتأثرة
UDI-DI: 04056869009964
الممثل المعتمد
SIEMENS HEALTHCARE LIMITED
سبب المشكلة
The potential of in very rare situations, the first x-ray release after patient registration might be performed with a wrong copper prefiltration.
الإجراء التصحيحي
As a workaround until the corrective action is implemented, the manufacturer recommends taking any action that leads to a change of the prefiltration prior to the first x-ray release after a patient registration. This could be the first acquisition, the change of the organ program, or changed water values due to steeper angulation. This resolves the current occurrence of this issue. A software update for the affected systems is planned by Siemens to correct the issue and ensure the correct function of the prefiltration. Manufacturer action: Instructions and correction.
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