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تسجيل جديد
الجمعة - ربيع الأول 13, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
تواصل معنا
EN
SA-30-09-24-608
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Zenition 50 and Zenition 70 systems
الأجهزة المتأثرة
Product Description - Product Code - Product UDI Zenition 50 - 718096 - (01)00884838091535(21) Zenition 70 - 718133 - (01)00884838091528(21)
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd
سبب المشكلة
The 5-Ampere Mains Control Unit (MCU) board fuse may blow out during the system start-up or during an ongoing procedure. When this issue occurs, the system will display a combination of error messages M326, M050 and M501 during a system start-up and M370, and M501 during an ongoing procedure.
الإجراء التصحيحي
Affected systems may continue to be used in accordance with their intended use and Instructions for Use (IFU). The 5-Ampere MCU board fuse will be replaced by Philips with a 10-Ampere MCU board fuse in all affected systems (reference FCO71800109). Updated Action: Philips has updated the actions to be followed by the users/customers, and also updated the information under the Hazard/Harm section. Please refer to the attachment for details. Manufacturer Action: Instructions and replace parts.
المرفقات
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