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الجمعة - ربيع الأول 13, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-23-09-24-603
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Trilogy Evo, Trilogy Evo O2, Trilogy EV300
الأجهزة المتأثرة
Trilogy Evo, Trilogy Evo O2, or Trilogy EV300 device. Any devices historically used with an in-line nebulizer in certain configurations are susceptible to below problem.
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd.
سبب المشكلة
Nebulized aerosols that accumulate over time have the potential to permanently impact the internal flow sensor.
الإجراء التصحيحي
Customers to follow the actions that should be taken by the customer / user found in the attachment. Philips Respironics is continuing to investigate this issue and will follow- up with customers to provide additional guidance and solutions as it becomes available. Action Update: Philips is providing further guidance for customers to determine what immediate actions and service requirements are necessary for their devices. Customers are to follow the added guidance provided within Appendix B of the attachment, in addition to the guidance provided in the previously communicated FSCA letter, which is repeated in the attachment for convenience. Manufacturer Action: Instructions and Correction.
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