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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-13-11-24-672
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Philips Allura Xper R7.6- R8.1 systems
الأجهزة المتأثرة
Allura Xper FD10 (722010) Allura Xper FD10 OR Table (722022) Allura Xper FD10/10 (72201) Allura Xper FD20 (722012) Allura Xper FD20 OR Table (722023) Allura Xper FD20 Biplane (722013) Allura Xper FD20 Biplane OR Table (722025)
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd
سبب المشكلة
There are potential safety issues with delayed LTE kit installations for Allura R7.6-R8.1 systems exceeding 10 years of life. The kit includes a propeller motor clamping bolt and the X-ray tube locking bolt. If one of these bolts breaks, part of the system will not function as expected.
الإجراء التصحيحي
Affected systems may continue to be used in accordance with their Indications for Use and Instructions for Use (IFU). If you experience erratic movements of the C-arm and/or if you see a portion of black area on the X-ray image, please call your local Philips representative to report the event. You will be contacted by Philips representative to arrange for a Field Service Engineer visit to install a Lifetime Extension Kit (reference FCO72200598). Manufacturer Action: Instructions and Correction.
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