التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

The customers/users are instructed by Philips to follow the following instructions:

- Provide power to the device when it is off so automated tests can run, as part of routine maintenance. Continue to observe the Ready for Use (RFU) Indicator to confirm the device’s readiness. See “Maintenance” in the Efficia DFM100 Instructions for Use (IFU).

- You may continue to use your Efficia DFM100 if your device does not exhibit the issue described in this notice. If you identify a device that exhibits this behavior, please remove the device from service and contact your local representative.

- Customers should back up device data (patient event records and device logs) prior to the software upgrade as device data will be erased during the upgrade — see “Data Management Philips Reference#: FSN-2025-CC-EC-018, FCO86100240 Page 3 of 5
Mode” in the DFM100 IFU for patient event record export and “Export Device Info” in the Service Manual for device logs export.

The software solution has been released (SW 2.00.46 or higher), and Philips will correct the affected devices that have SW 2.00.33 installed.

Manufacturer action: Instructions and correction.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-19-12-25-1189