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السبت - جمادى الآخرة 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-24-10-25-1108
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اسم الجهاز الطبي
Philips CT Systems
الأجهزة المتأثرة
Product Number (Product Model, Device Identifier): 728143 (Incisive CT, 00884838085015) 728144 (Incisive CT, 00884838105508) 728146 (Incisive CT for Brazil SKD, NA) 728148 (Incisive CT Power, 00884838103467) 728149 (Incisive Plus, 00884838103474) 728151 (Incisive CT Essentials, 00884838103481) 728134 (Philips CT 3500, 00884838111318) 728138 (Philips CT 3500 Essentials, 00884838105522) 728139 (Philips CT 3500 Plus, 00884838105539) 728285 (CT 5300, 00884838113237)
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd
سبب المشكلة
Philips has identified an issue that may occur with the Philips Incisive CT, CT 3500 and CT 5300 systems if the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Philips CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
الإجراء التصحيحي
Please continue to use your system in accordance with its intended use and do not stay in the scan room when scanning. Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect the tube heat exchanger screws and correct the loosen screw if necessary. Manufacturer's Action: Instructions and Correction.
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