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مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-22-04-24-378
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
HIGH FLOW INSUFFLATION UNIT
الأجهزة المتأثرة
Model: UHI-4 Description: Insufflator, UHI-4, 220-240V Material ID (UDI): N3829650 (04953170435881); N3829660 (04953170324154); N3829670 (04953170324161) Serial numbers: All purchased before August 2024
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
Complications may experiencing due to over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.
الإجراء التصحيحي
The new software version corrects a pressure sensor failure detection algorithm. The UHI-4 should be considered to remain quarantined at your site until the following corrections are completed: • Units manufactured before October 2019 requires both a CR Board replacement and a software update • Units manufactured after October 2019 requires a software update only Once the required correction(s) has been performed, you no longer need to quarantine the UHI-4, refer to the attachment for more details.
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