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تسجيل جديد
الأحد - ذو الحجة 5, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-12-03-25-810
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Venue Go / Venue Fit Ultrasound systems
الأجهزة المتأثرة
Venue Go R2 system (GTIN 00840682138840) Venue Go R3 system (GTIN 00840682190503 / GTIN 00195278358011) Venue Go R4 system (GTIN 00195278516510 / GTIN 00195278516527) Venue Fit R3 system (GTIN 00195278194275 / GTIN 00195278361400) Venue Fit R4 system (GTIN 00195278516497 / GTIN 00195278516503) Updated Codes: The following codes were added: Venue Go R5 system (GTIN 00195278450319 / GTIN 00195278451774) Venue Fit R5 system (GTIN 00195278424938 / GTIN 00195278425041) Please refer to the attachment for more details.
الممثل المعتمد
General Electric Healthcare Arabia
سبب المشكلة
The battery for certain Venue Go and Venue Fit ultrasound systems with software versions R2, R3, and R4 can potentially develop an internal failure which could result in smoke or fire.
الإجراء التصحيحي
You can continue to use your Venue Go and Venue Fit system after following the actions below: 1) Turn the system ‘Off’ and unplug the system from the wall socket. 2) Remove the system batteries by following instructions provided in the User Manual Chapter 3. These instructions are also provided in the attachment in Appendix A for Venue Go and in Appendix B for Venue Fit. 3) Check the date of manufacture of the system batteries by looking at the label on the bottom of each battery. 4) Calculate the age of each of the system batteries. 5) If any of the batteries are more than 2 years old: a. With the system unplugged, re-insert batteries, turn the system ‘On’ and leave the system ‘On’ to discharge the batteries. b. Once the battery capacity indicator shows two segments or less, turn the system ‘Off’ and remove the batteries per step 2. c. Dispose of batteries according to local regulations. NOTE: After battery removal, you can continue to use the system with use of AC power cord. The system is fully functional without the battery. 6) If the batteries are less than 2 years old, you may continue to use the battery until the battery reaches 2 years old, at which point, repeat instructions in step 5. You will be contacted by GE HealthCare representative you to arrange for the correction. After the correction has been implemented, please be sure to destroy the installation media for affected software at your site. Manufacturer action: Instructions and correction.
المرفقات
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