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الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-02-10-25-1077
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
AVVIGO™+ Multi-Modality Guidance System
الأجهزة المتأثرة
Please refer to the attachment.
الممثل المعتمد
Boston Scientific Gulf for trading LLC
سبب المشكلة
A software anomaly that occurs when the AVVIGO™+ Multi-Modality Guidance System is connected to the OptiCross™ 18 Peripheral Imaging Catheter and either Live or Record mode is in use, the grid mark overlay on cross-sectional view will not display correctly.
الإجراء التصحيحي
Please read carefully the attachment and immediately post it in a visible location near the AVVIGO+ Multi-Modality Guidance System to ensure this information is easily accessible to users. It is recommended by Boston Scientific using the measurement tools, available in Review mode only, to take vessel measurements (refer to detailed instructions included within the AVVIGO+ Multi-Modality Guidance System Instructions for Use, IFU). If measuring using grid mark overlay is preferred, it should only be performed in Review mode. Additionally, a physician can manually adjust the depth settings through the ‘Case Settings’ menu or elect to remove the grid marks from the display at time of use. Boston Scientific is developing a software update to address this anomaly. Manufacturer's Action: Instructions and Correction.
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