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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-06-03-24-316
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Trilogy Evo, Trilogy Evo O2, and Trilogy EV300
الأجهزة المتأثرة
All Trilogy Evo, Trilogy Evo O2, and Trilogy EV300
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd
سبب المشكلة
Multiple of safety issues what were previously communicated in different safety alerts: 1. Accuracy of Oxygen Delivery 2. Environmental Contamination of Device Sensor. 3. Battery Depleted or Loss of Power Alarms Triggered. 4. Incomplete Contraindications Statement. In addition, other non-safety related issues not previously communicated and will be addressed too.
الإجراء التصحيحي
Philips is releasing the mandatory software update, version 1.06.10.00, and a User Manual addendum to resolve all software-related issues and labeling-related issues detailed in the attachment. Please follow actions that should be taken to prevent risks for patients or users in the attachment.
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