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السبت - ذو القعدة 12, 1446
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EN
SA-26-07-24-532
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
FREEGO ENTERAL FEEDING PUMP
الأجهزة المتأثرة
Ref (GTIN / EAN): S400054 (05391503600473), S400015 (05391503600480), S400A58 (05391503600497), S400A53 (05391503600503), S400029 (05391503600510), S400042 (05391503600527), S400063 (05391503601883), S400A24 (05391503600534), S400A52 (05391503600541) All serial numbers
الممثل المعتمد
Abbott Saudi Arabia For Trading LLC
سبب المشكلة
Software issue which may cause a potential malfunction of the FreeGo Pump. This issue may lead to the pump not alarming for an occlusion, or blockage, even if an occlusion exists which could lead to no feed being delivered.
الإجراء التصحيحي
Please refer to "Recommended actions to be taken by the Healthcare Professionals, Caregivers, and Users" in the attachment. A software update is being developed by Moog to resolve this issue for the FreeGo pumps. NCMDR Updated action: The new version of FreeGo pump software is now available. Abbott will contact all users to arrange the replacement/update of pumps currently in the field and provide pumps that contain the new software. Please continue to follow the additional instructions as previously provided in the attachment.
المرفقات
عودة للقائمة