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الجمعة - شعبان 11, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-25-01-26-1235
التفاصيل
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الشركة الصانعة
اسم الجهاز الطبي
BECKMAN COULTER DxC 700 AU and BECKMAN COULTER Chemistry Analyzer AU5800
الأجهزة المتأثرة
Please refer to the attachment for details of affected products.
الممثل المعتمد
Beckman Coulter Saudi Arabia Co Ltd
سبب المشكلة
It has been determined by Beckman Coulter that the affected DxC 700 AU and AU5800 Clinical Chemistry Analyzers may unexpectedly generate the errors described below when transitioning from Standby to Measure 1, or from Measure 2 to Measure 1, using PC pre-installed with Microsoft® SQL Server® 2022 Express, and analysis may not be started: • 9000 PROGRAM ERROR (... CAL History DB Open Error.(SqlErr) ...) • 9000 PROGRAM ERROR (... RB History DB Open Error.(SqlErr) ...)
الإجراء التصحيحي
• The above issue will be resolved by applying a Software solution to the impacted systems. BEC service team will contact you to schedule the Software solution application, and a Field Service Engineer (FSE) will perform the on-site work. • Until the Software solution is installed, please follow these precautions: - Do not leave the Calibration Monitor open for more than 15 minutes (including the five tabs under the Calibration tab: Status, RB History, RB Detail, Calibration History, Calibration Detail) even in modes other than Measure mode, such as Stand-by mode. - Perform System Shutdown (END Process) daily. (This backs up the RB and Calibration databases.) For AU5800, ensure the backup checkbox is selected during System Shutdown. DxC 700 AU does not have a checkbox as backup is done automatically when System Shutdown process. Refer to the attachment for more information. Manufacturer's action: Instructions and Correction.
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