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الجمعة - محرم 2, 1447
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أسئلة شائعة
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EN
SA-09-10-24-620
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
OmniWire Pressure Guide Wire Internal Wire
الأجهزة المتأثرة
All OmniWire Pressure Guide Wires manufactured since February 2022 (2022-02-01) are potentially impacted.
الممثل المعتمد
IKAR Trading LLC
سبب المشكلة
Internal wire component could become damaged due to the wire potentially not meeting an internal specification.
الإجراء التصحيحي
Continued use of the OmniWire Pressure Guide Wire should be according to the Instructions for Use (IFU). If any loss of signal were to occur during use, replace the wire with another OmniWire to complete the procedure. If you experience any signal issues when using the OmniWire, please notify your local representative so that they can file a complaint and request for replacements.
المرفقات
عودة للقائمة
