التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

The above issue can only be identified by qualified personnel from Siemens service organization. To help mitigate any potential risks, please ensure the steps mentioned in the attachment are taken.

Siemens Healthineers is preparing an inspection and, if necessary, a correction that will resolve this potential issue.

Manufacturer action: Instructions and Correction.
..............................................................................................................................................................

NCMDR updated action:
If the expert assessment from Siemens after inspection identified an unacceptable level of ice in the primary venting path. The following immediate actions are required:

-              Immediate stop use of the system.
-              All access to the scanning room must be blocked/secured with the system remaining at field.

A Siemens representative will perform a comprehensive de-icing procedure to your system.

..............................................................................................................................................................

NCMDR updated action:

If the error message shown un the attachment appears on your host computer, no further scans can be performed, and you are requested to:
-	Not reboot the system.
-	Remove the patient from the system.
-	Lock/Secure all access to the scanning room with the system remaining energized at field.
-	Post a “DO NOT USE” notice on or near the device.
-	Call Siemens Healthineers service organization as requested In the error message.
In addition, and in accordance with the instructions for use, Siemens reminds you that:

-	The Magnet Stop is only intended for emergencies. DO NOT initiate a manual quench of the magnet unless there is an emergency.
-	Ensure all designated emergency exit routes remain unobstructed at all times and are properly marked, in particular, the exit from the examination room must be maintained at all times.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-17-08-25-1006