التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

This notification is to inform you of an update to the Urgent Medical Device Correction Letter Philips previously sent to your facility, dated October 23, 2023 (attached for reference).

Philips is providing an update on the development of the action plan:

•	Philips is in the process of developing a field correction, which will introduce new software risk control measures to prevent smoke/fire by prohibiting customers from continued scanning if Gradient amplifier errors reach a threshold and triggers a system interlock. If this system interlock occurs thus preventing further scanning, an FSE will come to your site to investigate the issue and if it is identified that there is a problem with the gradient coil, it will be replaced.

•	A longer-term follow-up correction is also being developed to implement a new smoke detector interlock for the affected systems. The smoke detector interlock is designed to prevent further scanning (an interlock) when smoke is detected in the area. The interlock cannot be lifted until a Philips FSE visits your site to investigate the cause of the issue.
----
Action updated:

- Philips has identified additional Multiva 1.5T systems which are being included in the scope of this recall.
- Section 5 of the Field Safety Notice Letter has been updated to include up to date information regarding the field corrections.
- The previous plan to implement a Smoke Detector Interlock has been modified and instead, Philips is exploring if materials in the vicinity of the gradient coil need to be replaced with better (more) flame-retardant alternatives. Once all the materials are assessed a plan will be put in place to deliver this material change.

Please refer to the attachment for details.

Manufacturer action: Correction

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-25-10-23-117