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الجمعة - جمادى الآخرة 26, 1446
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بحث عن منتج
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أسئلة شائعة
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EN
SA-15-09-24-594
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Soltive™ SuperPulsed Laser System
الأجهزة المتأثرة
Name (Material ID, Model, UDI): SOLTIVE Pro SuperPulsed Laser System (EGTFL-SLS, TFL-SLS, 00821925044135) SOLTIVE Premium SuperPulsed Laser System (EGTFL-PLS, TFL-PLS, 00821925044111) Serial Numbers: All
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
The term “Bladder Stone” was incorrectly translated in both Spanish and Portuguese to “Kidney Stone” (Cálculo renal) on the systems’ Graphical User Interface (GUI). As a result of the incorrect Spanish and Portuguese translation from “Bladder Stone” to “Kidney Stone” on the GUI, there is a potential to deliver an incorrect or unintended amount of energy to the patient’s anatomy. This issue is specific to the preset laser settings and does not affect users who are not utilizing the preset option.
الإجراء التصحيحي
Olympus reminds users to verify that the settings for the intended procedure are indicated on the Treatment Screen in Standby Mode before transitioning to Ready Mode, refer to the attachment for more information. Olympus will be issuing a software update to correct the translation error in the coming months and will contact you at that time to coordinate the update for your unit(s).
المرفقات
عودة للقائمة
