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السبت - ذو القعدة 12, 1446
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SA-17-07-24-515
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
ProCuity® beds
الأجهزة المتأثرة
Part number: 300900000000 3009PX-L-100 3009PX-L-200 3009PX-LE-400 3009PX-LE-450 3009PX-LEX-400 3009PX-LEX-450 3009PX-Z-450 3009PX-ZM-450 3009PX-ZM-600 3009PX-ZMX-450 3009PX-ZMX-600 3009PX-ZX-450 Serial number(s): 2201001090 2105002771 2202002136 2207001642 2207001646 2207001648 2207001703 2207001729 Please refer to the attachment for more details.
الممثل المعتمد
ALJEEL MEDICAL COMPANY
سبب المشكلة
It has been identified that the manufacturing records for certain ProCuity beds are missing test values for electrical safety tests as required by IEC 62353:2014.
الإجراء التصحيحي
You will be contacted by Stryker representative to arrange a time to complete the required electrical tests: a. Dielectric voltage-withstand (HIPOT) test in accordance with IEC 60601-1. b. Ground Continuity test as required annually per the PM checklist in the device Operations/Maintenance Manual. Please refer to the attachment for more information.
المرفقات
عودة للقائمة
