التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

The following actions shall be taken by the user of the device:
1. Identify whether any of your DI-60 analyzer(s) are affected.
2. If your unit(s) are affected, please implement the following interim measure to mitigate the risk of sample misattribution:
     a. Before signing each order, confirm that the number of slides in the order matches the number of slides ordered. No order                        
         shall contain more slides than prescribed.
     b. Await contact from Sysmex service personnel, who will arrange installation of the updated CCU firmware.
3. You may continue to use the system(s) in accordance with its intended use, provided the above instructions are followed
4. Retain the attachment until the firmware correction has been implemented. Ensure that the attachment is kept in a visible and accessible location.

A new Firmware (version 4.2.7) has been developed by the manufacturer to solve the problem associated with the barcode reader. The installation will be performed by Sysmex service personnel, who will contact affected users to schedule a time for firmware update.

Manufacturer's Action: Instructions and Correction.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-14-10-25-1093