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السبت - جمادى الآخرة 1, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-13-11-25-1148
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
DEFIGARD Touch7 monitor and defibrillator
الأجهزة المتأثرة
DEFIGARD Touch7 devices with software version SOFT10B17 or SOFT10B18 and a serial no. lower than 128960006000
الممثل المعتمد
Medical Supplies and Services Co Ltd
سبب المشكلة
Technical alarms may appear randomly during use. These alarms take the form of a message on the screen "ECG Module inoperative" or "DEFI Module inoperative" and malfunctioning of the ECG or Defibrillation functions. This could delay the treatment of the patient.
الإجراء التصحيحي
If the fault occurs during use, restart the device immediately to return to normal operation. If the software version of your DEFIGARD Touch7 is SOFT10B17 or SOFT10B18 and its serial no. is lower than 128960006000, please update it to version SOFT10B19 without delay. If the software version of your DEFIGARD Touch7 is lower than SOFT10B17, please update it to version SOFT10B19, as soon as possible to integrate the maintenance test. This new version is available from your SCHILLER distributor, and they will provide any assistance you need with installing it. Manufacturer's Action: Instructions and Correction.
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