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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-16-04-25-859
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Portrait™ Mobile Monitoring Solution v1.1
الأجهزة المتأثرة
Product: Portrait Core Services v1.1 Model: CSSXB Part Number: 5700209 GTIN: 00195278659446 Software Version: 1.1.0 / 1.1.1
الممثل المعتمد
General Electric Healthcare Arabia
سبب المشكلة
A software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.
الإجراء التصحيحي
You can continue to use your Portrait™ Mobile Monitoring Solution v1.1 product, since all potentially impacted systems were recently installed and the safety issue does not manifest until after 425 days of continuous use. Please follow the annual Maintenance Schedule described in Service Manual (PN 5929144) for your Portrait™ Mobile to reboot the system. Rebooting the system by following this procedure resets the continuous days of use to zero. GE Healthcare representative will contact you to arrange a software update. After the Portrait Core Services v1.1 software is updated and corrected by GE HealthCare, please discontinue usage of any Portrait Core Services v1.1 software versions 1.1.0 or 1.1.1 and destroy any software media containing those versions. Manufacturer action: Instructions and correction.
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