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الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-20-08-25-1018
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
GETINGE 88-5 Washer disinfector
الأجهزة المتأثرة
Getinge 88-5 Washer disinfector (all units with electrical heating). UDI DI: 07340153700109, 07340153700116. SRN: SE-MF-000001012.
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
There was a fire incident registered on a Getinge 88-5 washer disinfector, where smoke was emitted due to overheating of the heater element. The heater element was overheated and caused the insulation on cover plates to melt and create smoke. Other items like cables, hoses etc. did also melt and cause smoke.
الإجراء التصحيحي
Getinge proposes to verify that the pressure in the circulation system reads 0.0 kPa during stand-by mode to make sure all devices present in the market are working effectively and safely. If the pressure does not indicate 0.0 kPa, the device must be calibrated by a qualified technician. An instruction will be provided to support the verification process. Manufacturer's Action: Instructions and Correction.
المرفقات
عودة للقائمة
