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الجمعة - ربيع الأول 13, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-24-09-24-604
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
McGrath MAC Video Laryngoscope
الأجهزة المتأثرة
Item Code: 300-000-000 GTIN: 15060272980020 Affected Serial Numbers: All serial Numbers prior to 366170
الممثل المعتمد
Medtronic Saudi Arabia LLC
سبب المشكلة
Batteries that are depleted below the design threshold may increase the risk of the battery becoming unstable, which may lead to a thermal event followed by a risk of explosion. The issue and potential risks are the same for devices of all ages, within and beyond their useful life. These devices are now past their 5-year useful life and should be removed from service.
الإجراء التصحيحي
• Immediately discontinue use of all 300-000-000 devices. All 300-000-000 devices, irrespective of age, present the same risk to health outlined above. • Uninstall the battery assembly from the devices and dispose of both the device and battery per local procedures.
المرفقات
عودة للقائمة
