تسجيل الدخول
تسجيل جديد
الجمعة - محرم 9, 1447
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-14-01-25-737
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
3M Prevena Plus 125
الأجهزة المتأثرة
Please refer to the attachment for details.
الممثل المعتمد
ALJEEL MEDICAL COMPANY
سبب المشكلة
The affected products were released with a leak alarm threshold lower than the design specification. This results in the therapy unit prematurely alarming although there is no leak within the system and potentially continuing to alarm during therapy although there is no visible leak.
الإجراء التصحيحي
The company is instructing the customers to: - Immediately cease use and quarantine any identified product. - Contact the authorised representative to arrange the shipment of the affected products Products returned to Solventum will be assessed, reprogrammed, and returned or replaced. Manufacturer Action: Removal
المرفقات
عودة للقائمة