التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

For the 1st Generation Laryngoscopes model 300-000-000:
•	Immediately discontinue use of the affected devices.
•	Uninstall and dispose of the battery assembly from the affected devices.
•	Return the removed device to Medtronic.
•	Pass this notice on to all who need to be aware within your organization or to any organization where the potentially affected product with the specified serial numbers have been transferred or distributed. 
•	Please complete the enclosed Customer Acknowledgement Form even if you do not have affected inventory. 

For the 2nd Generation Laryngoscope model 301-000-000:
•	Continue using Next-Generation McGRATH™ Video Laryngoscopes Next-Generation.
•	Follow Important Battery Handling Information stated in the IFU and provided in this notice and maintain a copy of the addendum with the IFU for McGRATH™ MAC Video Laryngoscopes.
•	Pass this notice on to all who need to be aware within your organization or to any organization where the potentially affected product with the specified serial numbers have been transferred or distributed.
•	Please complete the enclosed Customer Acknowledgement Form even if you do not have affected inventory.

المرفقات