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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-17-10-24-631
التفاصيل
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اسم الجهاز الطبي
Vue PACS
الأجهزة المتأثرة
This issue affects all Philips Vue PACS image management systems which have the Perfusion Application license enabled.
الممثل المعتمد
Bio Standards LLC
سبب المشكلة
Potential for misdiagnosis due to incorrect ischemic map and tables values
الإجراء التصحيحي
-To prevent the issue from occurring, Philips recommends that users not use the perfusion application Export function (as shown in Figure 4). When used without export functionality, the perfusion application performs as expected. -You may continue to use your system(s) in accordance with the intended use and by following the recommendation above. -If a study is reloaded in the Perfusion Application after an export action is performed, and the Perfusion/Diffusion Warning message is observed (shown in Figure 1), the ischemic map and table value calculations should not be used for diagnostic purposes. -A Philips representative will contact you to schedule a time to install a software solution on your system(s) to resolve the issue (reference FCO78000003). Philips plans to begin installing the solution on affected systems in October 2024.
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