تسجيل الدخول
تسجيل جديد
الجمعة - ذو القعدة 11, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-25-09-24-607
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Ultraview DM3 Monitor and Spacelabs DM4
الأجهزة المتأثرة
Product Name : 1- Ultraview DM3 Monitor (all variations -M, -MT, -N, -NT) Product Number: 91330. 2- Spacelabs DM4 (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW) Product Number: 91331. Please refer to the attachment for UDI-DI of affected product models.
الممثل المعتمد
Gulf Medical Co.
سبب المشكلة
The lithium-ion battery used in the DM3 and DM4 is susceptible to failure and overheating when used beyond its recommended lifetime or otherwise damaged.
الإجراء التصحيحي
The Operations Manual and Service Manual for the DM3 and DM4 have been updated to convey the risks associated with continuing to use the lithium batteries past the specified use life and to clarify that batteries older than two years, damaged, or that are no longer holding a charge must be replaced. Users must download current versions of the Operations Manual and Service Manual and dispose of any previous copies. The updated product labeling is available via the Spacelabs user manual site at https://manuals.spacelabshealthcare.com/. Biomedical engineering must remove and replace any batteries that have been in use longer than two years, are damaged, or are no longer holding a charge. Biomedical engineering must arrange preventive maintenance to replace the batteries upon reaching the conclusion of their two-year use life.
المرفقات
عودة للقائمة
