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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-22-01-25-757
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اسم الجهاز الطبي
AD7 and AD7X patient tables
الأجهزة المتأثرة
The AD7 or an AD7X table types (tilt and non-tilt versions) are used with the Philips Allura and Azurion systems. Please refer to appendix A in the attachment for more details.
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd
سبب المشكلة
It has been identified by Philips that during manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop, possibly resulting in an injury of the finger.
الإجراء التصحيحي
Please follow the additional instructions when positioning the patient table included in Appendix B of the attachment. These instructions include information of potential finger entrapment areas when moving the table. Philips is releasing an addendum to the instructions for use and a Quick Reference Card. Philips is working on the design of additional brackets for the AD7 tables, and a new redesigned table cover for AD7X tables. Philips will contact customers to schedule a visit once the new redesigns are available. Manufacturer action: instructions and correction
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