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تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-28-07-25-980
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Enterprise Archive
الأجهزة المتأثرة
Please refer to the attachment.
الممثل المعتمد
General Electric Healthcare Arabia
سبب المشكلة
The imaging studies or images within a study may be associated with an incorrect patient following migration of historical studies to the Enterprise Archive (EA) in True PACS. It could potentially result in misdiagnosis or a delay in care.
الإجراء التصحيحي
When reviewing or exporting imaging studies after migration to EA, verify that the study and images within the study are associated with the correct patient by: 1) At the Study level: • Compare name, date of birth, and patient identifiers only if burned-in or embedded in the image. Do not rely on patient information in the image overlays that can be toggled on and off. • If burned-in or embedded patient identifiers are not available, compare with prior studies based on patient anatomy, implants, or unique anatomical features. 2) At the Image level: • Confirm the images within the study do not belong to different patients based on acquisition date and time or other patient identifiers. Manufacture correction: Correction.
المرفقات
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