التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

Affected systems may continue to be used in accordance with their Instructions for Use (IFU). 

Customers / users should establish an emergency protocol prior to all applicable diagnostics, interventional and minimally invasive procedures to manage the situation should they experience the issue during a procedure.

Philips will bypass the 1 Phase UPS in the affected systems. This will render the 1 Phase UPS inactive, preventing the occurrence
of the above-described issue. Not having the 1 Phase UPS connected will not affect system usage during normal operation.

Once the 1 Phase UPS is bypassed, controlled shutdown and data backup in the event of a hospital mains power interruption will no longer be available, which may cause the last acquired run to be lost when the power failure occurs during the acquisition or shortly after the run was acquired. Data loss from the last run on Azurion systems is not expected, as these systems are equipped with solid state drives (SSD).

Philips will contact all affected customers to schedule the execution of this activity.

Manufacturer action: Instructions and Correction

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-31-07-25-983