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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-02-12-24-694
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Tec 6 Plus, Tec 820, and Tec 850 Vaporizers
الأجهزة المتأثرة
Please refer to the attachment for a list of affected vaporizers and serial numbers.
الممثل المعتمد
General Electric Healthcare Arabia
سبب المشكلة
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
الإجراء التصحيحي
You can continue to use the vaporizer in accordance with the instructions in the User Reference Manual (URM) and the actions described below: Perform the Output Concentration Check described in Appendix 1 of the attachment for every impacted vaporizer (see Affected Product Details in the attachment). • If a vaporizer passes the Output Concentration Check, you can continue to use that vaporizer. GE HealthCare recommends use of anesthetic agent monitoring during vaporizer use. • If a vaporizer fails the Output Concentration Check, you can continue to use that vaporizer with anesthetic agent monitoring until GE HealthCare corrects the vaporizer. • If a vaporizer fails the Output Concentration Check and anesthetic agent monitoring is not available, remove the vaporizer from service. A GE HealthCare representative will contact you to arrange for the correction of affected vaporizers. Manufacturer Action: Instructions and Correction.
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