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الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-09-04-25-846
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
IntelliSpace Cardiovascular
الأجهزة المتأثرة
Reference Number: 830089 (software versions 6.1, 6.2, 7.0, 7.1, and 8.0)
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd
سبب المشكلة
It has been identified by Philips a software issue affecting IntelliSpace Cardiovascular (ISCV) software versions 6.x, 7.x, and 8.x. When using the Echo Module of ISCV, the issue may result in missing or incomplete information when Finding Codes are used to add information under certain circumstances.
الإجراء التصحيحي
Please refer to (Actions that should be taken by the customer / user in order to prevent risks for patients or users) in the attachment. Philips representative will contact the affected customers who use or may use the affected workflows according their responses to schedule a time to install the software solution on your system(s) to resolve the issue, refer to the attachment for more information. ---- Philips has updated the action: If you need to use a finding code more than once for a particular report profile: • Replace the duplicated finding code temporarily by using the manual text entry function while completing the report. • To replace the duplicated finding code in the database, use the clinical application tool to create a new finding code based on the original and replace it in the findings group. • You may continue to use your system(s) in accordance with the intended use and by following the recommendation above. A Philips representative will contact you to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issue Manufacturer action: Instructions and correction.
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