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تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
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EN
SA-18-05-25-895
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
SOLTIVE™ Premium SuperPulsed Laser System
الأجهزة المتأثرة
Models: Pro TFL-SLS and Premium TFL-PLS, and the SOLTIVE Laser Single Use and Reusable Fibers (Reference model numbers listed in the attachment).
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
A potential for unexpected smoke, sparks, flare, burning of a device or equipment, unsteady flames, steady flames and burns to a clinician or supporting staff occurring while using the SOLTIVE Laser Systems and SOLTIVE Laser Fibers.
الإجراء التصحيحي
supplemental guidance details the steps to detect fiber damage. Ensure all surgeons and personnel are completely knowledgeable and thoroughly trained on the content of this letter, the instructions provided for detecting fiber damage, Appendix 1, and the SOLTIVE Laser System and Fibers Instructions for Use. Include a copy of this letter with the Instructions for Use. You may continue to use the device as per this letter and the Instructions for Use. The users are instructed to: 1. Carefully read the content of the attachment, including Appendix 1 detailing the relevant Instructions for Use sections. 2. Ensure all surgeons and personnel are completely knowledgeable and thoroughly trained on the content of the attachment, the instructions provided for detecting fiber damage, Appendix 1, and the SOLTIVE Laser System and Fibers Instructions for Use. Include a copy of the attachment with the Instructions for Use. You may continue to use the device as per the attachment and the Instructions for Use. Manufacturer action: Instructions.
المرفقات
عودة للقائمة
