التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

• Circulate the attachment to all users of the system so that they are aware of the issue.

• Avoid rapidly pressing and releasing the footswitch pedals.

• In case X-ray functionality is not available following the situations described in the attchment, perform a cold system restart of the system, as follows:
o On the Review Module, press and hold “Power Off”.
o Release the button when the indicator light begins to flash.
o When the indicator light stops flashing, wait for 10 seconds.
o On the Review Module, press and hold “Power On”.
NOTE: Do not operate any of the controls while the system is powering on, as this may inhibit the start-up process

• Keep the attchment with the documentation of the system until Philips corrects your system. Ensure that the attchment is in a place likely to be seen/viewed. 

Philips will address the identified issue by implementing a software update in all affected systems. For systems featuring an Interventional Workspot and/or EchoNavigator, Philips will upgrade the Interventional Workspot and/or EchoNavigator software version to ensure compatibility with the updated Philips Azurion system software.

Philips representative will contact you to schedule a visit to install the software update once available.

Manufacturer Action: Instructions and correction.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-30-05-25-916