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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
تواصل معنا
EN
SA-07-03-25-805
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System
الأجهزة المتأثرة
Model Number: VH-4000, UDI: 00607567700406 Model Number: VH-4001, UDI: 00607567700451 All unexpired lots
الممثل المعتمد
Medical Elements Co
سبب المشكلة
The potential the following two failure modes experienced during use: 1. A bent or detached heater wire. 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool. ------ Update: Getinge has revised the Instructions for Use (IFU) for the Vasoview Hemopro 2 EVH System.
الإجراء التصحيحي
Customers should follow the "Actions to be taken by the customer" provided in the attachement and review the IFU information provided in Appendix A of it. ----- Update: * Customers to review the updated IFU and share with any current and prospective users of the VasoView Hemopro 2 Endoscopic Vessel Harvesting System within their hospital/facility. * Getinge has created a training video, accessible via the QR code or link in the attachment, to guide users on the proper use of the device and reinforce essential precautions. Manufacturer action: Instructions.
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