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الأحد - ربيع الآخر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-08-08-24-547
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Azurion 7 M20 with FlexArm stand
الأجهزة المتأثرة
Model number: 722079, 722224, 722234
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd
سبب المشكلة
Philips has identified that the motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. And it could potentially lead to a delay or termination of the procedure. --- October 2025 update: Philips communicated earlier that it was working on a design solution (namely, redesigned longitudinal bearings), which was expected to be ready by Q3 2025. In the meantime, Philips has determined that the aforementioned design solution does not effectively resolve the issue and that additional investigation is necessary to find a suitable design solution.
الإجراء التصحيحي
Please check the attachment for the actions that should be taken by the customer/user in order to prevent risks for patients. Philips will replace the existing longitudinal bearings on the affected Azurion 7 M20 systems with FlexArm stand with redesigned longitudinal bearings. --- October 2025 update: Until the new design solution is available and implemented in affected systems, Philips will start to remotely evaluate log files for this issue. For affected systems not connected under a remote monitoring agreement with Philips, Philips is offering customers to sign up for free remote monitoring of this issue. The updates also include additional information to consider in case the C-arm is moved manually. Manufacturer action: correction
المرفقات
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