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تسجيل جديد
الأربعاء - جمادى الآخرة 12, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
تواصل معنا
EN
SA-27-11-25-1164
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
OTESUS OR table column
الأجهزة المتأثرة
Model Number (UDI; Model Name; Serial/Lot Numbers): 116001A0 (04046768100657; OTESUS OR table column, stationary; SN 3754 – 3782 (26 devices)) 116001B0 (04046768100664; OTESUS OR table column, stationary; SN 459 (1 device)) 116001C0 (04046768100671; OTESUS OR table column, mobile; SN 4137 - 4189 (18 devices)) 116001D0 (04046768122161; OR table column, manoeuvrable; SN 1323 – 1337 (11 devices))
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
The new LEDs of the Optic and contact carrier module can cause interfering signals (Wider beam angle) between the OR-Table Columns and the OR-Table Tops.
الإجراء التصحيحي
The device can be used in accordance with the instructions for use. If one of the errors that are mentioned in the attachment due to interfering signals occurs and no key on an input device is pressed for at least 15 seconds, the system goes into standby. If the desired command is pressed again on an input device afterwards, there is a possibility that it will be executed before one of the described errors occurs again. • Getinge representative will contact you to schedule the correction. • Getinge will perform a corrective action to solve the issue. Manufacturer's Action: Instructions and Correction.
المرفقات
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