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الأربعاء - جمادى الآخرة 26, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-15-12-25-1181
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Neurostimulator Vanta™ with AdaptiveStim™ Technology
الأجهزة المتأثرة
Model Number: 977006 UDI/ GTIN: 00763000478087 PIN number: 977006002H
الممثل المعتمد
Medtronic Saudi Arabia
سبب المشكلة
In March 2022, Medtronic began notifying customers of Vanta™ Implantable Neurostimulator (INS) Model 977006, may be susceptible to not communicating with the clinician programmer and/or the patient programmer system (HH90 Handset and TM91 Communicator). Medtronic has since developed and released updated firmware for the Vanta INS device to address the potential communication issue.
الإجراء التصحيحي
• Return unused affected devices to Medtronic. • Complete the enclosed Customer Acknowledgement Form and return it to Medtronic. • This notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. • Please maintain a copy of this notice in your records. Manufacturer Action: Removal
المرفقات
عودة للقائمة
