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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-29-03-25-835
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
ZOLL Powerheart® G5 AED Product Family
الأجهزة المتأثرة
Model/ Catalog Number: G5X-XXX
الممثل المعتمد
Mohammed Binmahfouz Trading Est
سبب المشكلة
The potential for after normally scheduled self-tests the AEDs have displayed Error Code (EC) 501 and cannot deliver lifesaving therapy. This failure mode is likely due to exposure to humidity outside the device’s published specification.
الإجراء التصحيحي
Customers who have AEDs should routinely: 1- Monitor device for self-test results. 2- For customers who experience a self-test failure, take action to resolve any alerts as soon as possible. Customers who have at-risk devices should immediately: 1- Ensure users have a program in place that periodically monitors the status of these devices, in accordance with G5 User’s Guide. 2- EC 501 is likely due to exposure to humidity outside the device’s published specification. Ensure devices are stored within the device’s published specifications: • Temperature: 0°C to 50°C (32°F to 122°F) • Humidity: 10% to 95% (non-condensing) Manufacturer action: Instructions.
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