Company: Philips Ultrasound, Inc.
Date of Enforcement Report 12/24/2014
Class lI:
PRODUCT
EPIQ 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. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.
Recall Number Z-0816-2015
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
88 units (42 in the US and 46 outside US))
DISTRIBUTION
Nationwide and Internationally
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