تسجيل الدخول
تسجيل جديد
الاثنين - ذو القعدة 21, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-06-04-25-841
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
4008 S V10 hemodialysis machine
الأجهزة المتأثرة
- 4008 S V10, Product Code: M204001 - Spare part: Solenoid valve V84, Product Code: M388601 (produced in CW49/2024 – CW05/2025) See Appendix 1 in the attachment for more details.
الممثل المعتمد
Fresenius Medical Care Deutschland GmbH
سبب المشكلة
Potentially leaking disinfection valve (V84) in the 4008 S V10 hemodialysis machine.
الإجراء التصحيحي
Potentially affected devices and those that received the above-mentioned spare parts need to be checked and affected solenoid valves need to be replaced. Until a Fresenius Medical Care technician has performed the checks, Fresenius Medical Care recommends that healthcare providers do the following: - The affected 4008 S V10 devices (see Appendix 1 in the attachment) and those that received the mentioned spare parts must not be used for treatments until the solenoid valve V84 has been replaced. Please also discard and replace the disinfectant canister used for those affected devices. - Please apply adequate treatment by other means. Consult the responsible physician. Manufacturer action: Instructions and correction.
المرفقات
عودة للقائمة
