![]() ![]() Philips has identified additional affected units and sent the Urgent-Field Safety Notice -Philips Ultrasound QLAB 10.0 (on Xcelera) letter, dated 7, to their consignees. ![]() An incorrect EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy. Qlab philips manual#When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the ESV and EF calculated by manual tracing without the use of QLAB. System, imaging, pulsed doppler, ultrasonic - Product Code IYNĮPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Class 2 Device Recall EPIQ 5 Ultrasound System, Model: EPIQ 5G, EPIQ 5C, EPIQ 5W ![]()
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