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تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
تواصل معنا
EN
SA-16-07-24-513
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Horizon X-Ray Bone Densitometer (DXA)
الأجهزة المتأثرة
Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI UDI: 15420045505384; 15420045505698; 15420045505827; 15420045505834; 15420045505865 Refer to the attachment for affected Serial Numbers.
الممثل المعتمد
Medical Supplies and Services Co Ltd
سبب المشكلة
It has been identified a non-conformance in Horizon DXA devices was identified. The non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601 – 1 – 2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the electromagnetic compatibility limit.
الإجراء التصحيحي
Recommendations for customers: - Do NOT scan patients that have active implanted medical devices, including but not limited to neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors. - Any operator who has an active implanted medical device should also refrain from operating the system at this time. - Do NOT scan patients that are currently being treated with an electronic medical device. Until the rectification is completed, the attachment and the specific warnings within it supersedes information provided on the Horizon DXA labelling and IFU pertaining to electromagnetic compatibility and electromagnetic interference, refer to the attachment for more information.
المرفقات
عودة للقائمة
