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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 015 04 14 000
Date submitted: 4/2/2014
Manufacturer:Philips Healthcare
Device Type:EPIQ 5 Ultrasound System
Description:Ultrasound System
Medical Device Identifier:All Philips Model EPIQ 5 Ultrasound System at software version less than V1.1.2
Reason of Field Safety Corrective Action:Erroneous Velocities May Be Reported When Using High Pulse Repetition Frequency (HPRF)
Remedy Action:-Do not use HPRF in PW Doppler mode until the system is upgraded to V1.1.2

-Philips Field Service Engineer will be contacting you to schedule the V1.1.2 upgrade to your system free of charge
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (011) 2114547
Report Source:NCMDR
Source Ref. Number:EA41F3D93E335
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips.pdf