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السبت - جمادى الآخرة 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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تواصل معنا
EN
SA-12-10-25-1090
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Automated Impella Controller (AIC)
الأجهزة المتأثرة
All Automated Impella Controller (AIC) Device Model/Catalogue/part number(s): 0042-0010; 0042-0040; 0042-0000. Software version: All AIC Software version.
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
It has been identified by Abiomed cybersecurity vulnerabilities in the Automated Impella Controller (AIC). These vulnerabilities have residual risk related to network and physical access that could be compromised and that result in uncontrolled risks affecting the AIC Operating System.
الإجراء التصحيحي
-Keep the AIC in a secure environment with restricted access whether in clinical use or not. -Abiomed is working on security updates and measures to address these cybersecurity vulnerabilities. To mitigate the vulnerability risk, Abiomed field representatives will contact you to implement a USB driver isolation software patch and physical controls to eliminate vulnerability or, if requested by the customer, to arrange disabling the AIC’s network capabilities. The AIC may continue to be used as intended. Manufacturer's Action: Instructions and Correction.
المرفقات
عودة للقائمة
