X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 001 12 14 001
Date submitted: 12/11/2014
Manufacturer:Philips Healthcare
Device Type:EPIQ 7 Ultrasound System
Description:Philips Ultrasound System
Medical Device Identifier:EPIQ 7 Vi Ox/i .1 .x with QLAB a2DQ and/or aCMQ plug-ins

........................

Swissmedic update codes :

EPIQ 5 V1.0.x/1.1.x with QLAB a2DQ and/or aCMQ plug-ins
Reason of Field Safety Corrective Action:When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications to calculate End-Systolic Volume (ESV), the reported ESV may be smaller ESV calculated by manual tracing without the use of QLAB.
Remedy Action:-You can confirm whether your system is affected by checking the version of software on your system using the instructions attached on How to Identify Affected Products. Philips has corrected this issue in version i .2 and higher.

-If you have an affected version of software, please contact your local Philips representative to schedule an upgrade of your software.

-Until your software can be upgraded, you can avoid the situation by ensuring that you compute left ventricular volumes and ejection fraction by using either the on-cart manual analysis package or off-cart manual analysis package for your primary assessment.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:1C06422625AF
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Vk_20141203_13 ( Philips HealthCare ).pdf