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تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-04-06-25-921
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Hugo™ Robotic-Assisted Surgery (RAS)
الأجهزة المتأثرة
Product Description: SURGEON CONSOLE CFN: MRASC0001 GTIN: 10884521826625; Serial Number: C22AJA0155, C22AJG0215, C22AJK0267, C21AJK0136, C22AJF0201, C22AJF0209, C22AJC0164, C22AJA0161, C22AJC0179, C22AJF0206, C22AJF0203, C22AJE0196, C22AJH0221, C22AJE0191 GTIN: 10884521836235; Serial Number: C23AJH0385, C23AJA0309, C22AJM0279, C23AJB0323, C23AJC0338, C23AJH0396, C22AJM0286, C23AJB0330, C23AJB0321, C23AJB0335, C23AJC0348, C23AJF0370, C23AJL0427, C23AJB0332, C23AJF0373, C23AJL0428, C23AJA0296, C23AJB0333, C23AJC0339, C23AJC0345, C23AJC0346, C23AJH0384, C23AJC0351, C23AJK0421, C22AJM0283, C23AJF0369, C23AJA0306, C23AJB0320, C23AJB0325, C23AJC0340, C23AJC0341, C23AJC0352, C23AJF0374, C23AJF0380, C22AJF0211, C22AJM0294, C22AJM0295, C23AJA0298, C23AJC0344, C23AJF0376, C23AJH0393, C23AJH0395, C23AJH0398, C23AJJ0410, C23AJJ0411, C23AJJ0412, C23AJJ0413, C24AJF0498, C23AJC0336, C22AJM0281, C23AJA0304, C23AJF0366, C23AJF0375, C23AJB0326, C23AJB0327, C23AJA0300, C23AJA0301, C23AJA0312, C23AJA0313, C23AJJ0406, C23AJB0324, C23AJB0331, C23AJB0318
الممثل المعتمد
Medtronic Saudi Arabia LLC
سبب المشكلة
Potential for loss of power to the surgeon console due to failures of the surgeon console main power supply.
الإجراء التصحيحي
•Immediately notify all personnel in all care environments in which the Hugo TM RAS system is used about the Medical Device Correction attachment. •The continued use of Hugo™ RAS System is considered appropriate based on an internal review taking into account the benefit provided to patients compared to any potential risk that may be posed. This assessment may be augmented in individual surgeries by determining any circumstances that materially change the benefit or risk. •Your Medtronic representative will schedule a service call to inspect the impacted product and will service the device. Manufacturer Action: Instructions and correction.
المرفقات
عودة للقائمة
