Company: Philips Ultrasound, Inc.
Date of Enforcement Report 12/24/2014
Class lI:
PRODUCT
EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Part Number: 989605386721. Diagnostic Ultrasound Imaging.
Recall Number Z-0817-2015
REASON
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. An incorrect EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy..
RECALLING FIRM/MANUFACTURER
Philips Ultrasound, Inc., Bothell, WA on 11/5/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
701 units (237 in the US and 464 outside US)
DISTRIBUTION
Nationwide and Internationally
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